[Federal Register Volume 65, Number 148 (Tuesday, August 1, 2000)]
[Rules and Regulations]
[Pages 46864-46868]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-19302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201 and 341

[Docket No. 76N-052T]
RIN 0910-AA01


Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug 
Products for Over-the-Counter Human Use; Amendment of Final Monograph 
for OTC Antitussive Drug Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
amending the final monograph for over-the-counter (OTC) antitussive 
drug products (products that relieve cough). Use of topical/inhalant 
products containing camphor or menthol near a flame, in hot water, or 
in a microwave oven may cause the products to splatter and cause 
serious burns to the user. As part of its ongoing review of OTC drug 
products, FDA is adding warnings and directions to inform consumers 
about these improper uses and is amending its final regulations for OTC 
drug labeling requirements to add this new flammability warning for 
antitussive drug products containing camphor or menthol.

DATES: This rule is effective May 16, 2002. The compliance date for 
products with annual sales less than $25,000 is May 16, 2003. The 
compliance date for all other OTC drug products is May 16, 2002.

FOR FURTHER INFORMATION CONTACT: Elizabeth A. Ryland or Gerald M. 
Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 12, 1987 (52 FR 30042), the 
agency published the final monograph for OTC antitussive drug products. 
The monograph included the ingredients camphor and menthol as single 
topical antitussives in an ointment vehicle or for steam inhalation 
use. Products containing camphor and menthol in combination are being 
considered as part of the ongoing rulemaking for OTC cough-cold 
combination drug products.
    When the final monograph was published in 1987, the agency was not 
aware of safety problems occurring when products that contain camphor 
or menthol are added to hot water or used in a microwave oven. In the 
Federal Register of July 20, 1998 (63 FR 38762), the agency discussed 
new information concerning 34 fire-related events (flashing occurred) 
resulting from antitussive drug products containing camphor and menthol 
(in an ointment vehicle or an alcohol-based solution) that were placed 
in hot water or heated in a microwave oven. As a result, the agency 
proposed a flammability signal word and new warning and direction 
statements for these products (63 FR 38762 at 38765).
    The agency proposed a flammability signal word and a warning 
(``Keep away

[[Page 46865]]

from fire or flame'') for any product containing camphor or menthol in 
an ointment vehicle or for steam inhalation use. The agency also 
proposed a number of ``do not use'' warnings (e.g., near an open flame 
and in a microwave oven) and the following statements in the 
directions: ``See important warnings about not using near a flame, in 
hot water, or in a microwave oven. Improper use may cause the mixture 
to splatter and cause burns.''
    In response to the proposal, the agency received two comments, 
copies of which are on public display in the Dockets Management Branch 
(HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The 
agency's responses to the comments follow.

II. The Agency's Conclusions on the Comments

    (Comment 1) One comment agreed with the proposal to require 
additional information to help increase appropriate use of the topical/
inhalant drug products containing camphor and menthol.
    (Comment 2) Two comments requested that the regulation clarify that 
a flammability signal word is not required on all products. The 
comments pointed out that the flammability signal words in 16 CFR 
1500.3(b)(10) and (c)(6) state that ``flammable'' is any substance 
having a flashpoint above 20  deg.F and below 100  deg.F and that no 
flammability signal word is required if the flashpoint of the substance 
is above 150  deg.F. The comments added that camphor and menthol in 
ointment/cream products have flashpoints over 150  deg.F and would not 
need the flammability signal word or warnings, while steam inhalation 
products in an alcohol vehicle have a flashpoint between 20  deg.F and 
below 100  deg.F and would be labeled as flammable and contain the two 
proposed flammability warnings. One comment provided the results of 
flashpoint testing for its ointment, cream, and steam inhalation 
products (Ref. 1).
    The agency has reviewed the testing results and concurs that 
products with a flashpoint above 150  deg.F would not need the 
flammability signal word or warnings. The agency only intended that 
those products that meet the criteria in 16 CFR 1500.3(b)(10) 
(flashpoint of 150  deg.F or below) be labeled with the flammability 
signal word and warnings. Accordingly, the agency is revising 
Sec. 341.74(c)(5)(iii) (21 CFR 341.74(c)(5)(iii)) to require that the 
labeling contains the appropriate flammability signal word and the 
statement ``Keep away from fire or flame'' if the product meets the 
definition of one of the signal words (``extremely flammable,'' 
``flammable,'' ``combustible'') as described in 16 CFR 1500.3(b)(10). 
The agency is also amending Sec. 201.66(c)(5)(ii)(C) (21 CFR 
201.66(c)(5)(ii)(C)) to include Sec. 341.74(c)(5)(iii) as an example 
where a flammability warning is found in an OTC drug monograph.
    (Comment 3) Two comments requested that the warnings about not 
using these products in certain ways be included in the ``Directions,'' 
and not the ``Warnings,'' section. The comments contended that the 
warnings relate to appropriate use of the product and belong in the 
directions so consumers know how to use the product correctly. The 
comments argued that because space limitations on small package sizes 
make it very difficult to fit similar information in two places 
(warnings and directions), the information should be consolidated in 
the ``Directions'' section.
    The agency has determined that this information is more appropriate 
in the ``Warnings'' section of the labeling. Under the new OTC drug 
product labeling format in Sec. 201.66(c)(5)(vi), which was issued 
after the proposal in the current rulemaking, the subheading ``When 
using this product'' is used to describe activities consumers should 
avoid while using the product. Information about not using the product 
near a flame or in a microwave oven belongs under this subheading. 
However, because of the importance of the warning information, the 
agency is including a short cross-reference in the ``Directions'' 
section to the location of the information in the ``Warnings'' section. 
This approach is consistent with the ``choking'' warning for water-
soluble gums in 21 CFR 201.319 where the information about choking 
appears in the ``Warnings'' section and a cross-reference to the 
warning appears in the ``Directions'' section.
    The agency proposed a two-sentence cross-reference in the 
``Directions'' section that was repetitive of some of the information 
in the ``Warnings'' section. The agency is removing the repetitive 
information in the first proposed sentence (i.e., about not using near 
a flame, in hot water, or in a microwave oven) and shortening the 
sentence to refer users to the same information in the ``Warnings'' 
section. The revised directions statement now reads: ``[bullet] see 
important warnings under `When using this product' '' [appears as the 
first statement under the heading ``Directions'' and is highlighted in 
bold type]. The agency is moving the second proposed statement about 
the mixture splattering and causing burns to the ``Warnings'' section 
to follow the information about not using near a flame or in a 
microwave oven, because the second sentence should immediately follow 
that information.
    (Comment 4) Two comments requested that the directions provide 
different instructions for ointment and steam inhalation products. One 
comment suggested the following wording for ointment products: ``Do not 
expose to any heat source (including stove or microwave) or place in 
any container in which you are heating water. Improper use may cause 
the mixture to splatter and cause burns.'' The comment added that steam 
inhalation products would also include the word ``flame'' after 
``stove'' and the words ``except when adding to cold water in a hot 
steam vaporizer'' after the words ``heating water.''
    The second comment proposed similar but revised wording for 
ointment products: ``Do not heat. Never expose to flame, microwave, or 
place in any container in which you are heating water. Improper use may 
cause the mixture to splatter and cause burns.'' The comment added that 
steam inhalation products should also include the words ``except when 
adding to cold water in a hot steam vaporizer'' after the words 
``heating water.''
    As discussed in part II, comment 3 of this document, this 
information about not using the products in certain ways will appear in 
the ``Warnings'' section. The agency agrees that ointment, cream, and 
steam inhalation products could have slightly different warnings 
depending on the flashpoint of the products. The data provided by one 
comment (Ref. 1) showed that the flashpoints of an ointment product 
were 158 and 165  deg.F, while the flashpoint of a cream product was 
152  deg.F. As discussed in part II, comment 2 of this document, other 
manufacturers' products might have a flashpoint of 150  deg.F or below 
and thus be required to have a flammability signal word and warnings. 
The agency agrees with deletion of the word ``flame'' from the warnings 
for ointment/cream products if they are not flammable or combustible. 
The agency also agrees with inclusion of the words ``except when adding 
to cold water only in a hot steam vaporizer'' for steam inhalation 
products. To increase the amount of information provided to consumers 
and to state the information in a clear and concise way, the agency is 
revising the warnings as follows:
     For any product containing camphor or menthol in a 
suitable ointment vehicle and that does not contain a flammability 
signal word as described in 16 CFR 1500.3(b)(10). ``When using this 
product, do not  heat

[[Page 46866]]

 microwave  add to hot water or any container where 
heating water. May cause splattering and result in burns.'' 
[Information highlighted in bold type.]
     For any product containing camphor or menthol in a 
suitable ointment vehicle and that contains a flammability signal word 
as described in 16 CFR 1500.3(b)(10). ``When using this product, do not 
 heat  microwave  use near an open flame 
 add to hot water or any container where heating water. May 
cause splattering and result in burns.'' [Information highlighted in 
bold type.]
     For any product containing camphor or menthol for steam 
inhalation use. ``When using this product, do not  heat 
 microwave  use near an open flame  add to hot 
water or any container where heating water except when adding to cold 
water only in a hot steam vaporizer. May cause splattering and result 
in burns.'' [Information highlighted in bold type.]
    There are two types of products containing camphor or menthol for 
steam inhalation use on the market. One is formulated to be added 
directly to cold water inside a hot steam vaporizer before the water is 
heated, and the other is formulated to be placed into the medication 
chamber of the vaporizer. The agency is modifying the directions in 
Sec. 341.74(d)(2)(iv) and (d)(2)(v) for products containing camphor or 
menthol for steam inhalation use to include appropriate directions for 
both types of these products, as follows:
     For products formulated to be added directly to cold water 
inside a hot steam vaporizer.  use 1 tablespoonful of solution 
for each quart of water or 1\1/2\ teaspoonsful of solution for each 
pint of water  add solution directly to cold water only in a 
hot steam vaporizer  follow manufacturer's directions for using 
vaporizer.
     For products formulated to be placed in the medication 
chamber of a hot steam vaporizer.  place water in the vaporizer 
and follow manufacturer's directions for using vaporizer  place 
solution in the medication chamber only.
    (Comment 5) One comment stated that the proposed warning about not 
using an ointment product in a hot steam vaporizer is inappropriate 
(because these products are not used in that manner) and will lead to 
consumer confusion.
    The agency notes that 1 of the 21 fire-related events discussed in 
the proposal (63 FR 38762) involved an ointment product that was added 
to hot water in a vaporizer. The agency believes that it is important 
to inform consumers about this potential problem. The portion of the 
warning about not adding the product to ``hot water'' covers both hot 
water in a container on the stove and hot water in a vaporizer; thus, 
this information should adequately inform consumers and should not 
cause confusion.

III. Reference

    The following reference is on display in the Dockets Management 
Branch (address above) and may be seen by interested persons between 9 
a.m. and 4 p.m., Monday through Friday.
    1. Comment No. C200, Docket No. 76N-052T, Dockets Management 
Branch.

IV. The Agency's Final Conclusions

    The agency concludes that the case reports raise safety concerns 
that could be alleviated by providing consumers with additional 
warnings and directions for topical/inhalant OTC antitussive drug 
products that contain camphor or menthol. Products that meet the 
definition of one of the signal words (``extremely flammable,'' 
``flammable,'' ``combustible'') in 16 CFR 1500.3(b)(10) must state the 
signal word and ``Keep away from fire or flame'' in their labeling. 
Consumers need to be informed via warnings not to heat or microwave 
these products, not to add them to hot water, not to put them in any 
container where water is being heated (except for adding a steam 
inhalation product to cold water only in a hot steam vaporizer), and 
not to use near an open flame (if the product bears a flammability 
signal word). The agency has included warnings and directions with 
minor differences to fit the variety of products that might exist and a 
short cross-reference to the warnings information in the directions 
section. The agency has revised proposed warnings and directions in 
this final rule to state them in the new OTC drug labeling format 
required by Sec. 201.66.

V. Analysis of Impacts

    FDA has examined the impacts of this final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Under the Regulatory 
Flexibility Act, if a rule has a significant economic impact on a 
substantial number of small entities, an agency must analyze regulatory 
options that would minimize any significant impact of the rule on small 
entities. Section 202(a) of the Unfunded Mandates Reform Act requires 
that agencies prepare a written statement and economic analysis before 
proposing any rule that may result in an expenditure in any one year by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million (adjusted annually for inflation).
    The agency believes that this final rule is consistent with the 
regulatory philosophy and principles identified in the Executive Order. 
In addition, the final rule is not a significant regulatory action as 
defined by the Executive Order and so is not subject to review under 
the Executive Order.
    The purpose of this final rule is to revise and improve the 
labeling (add additional warning and direction statements) for safer 
use of topical/inhalant products that contain camphor, menthol, or both 
ingredients. This revised labeling addresses the flammability of these 
products and alerts consumers not to heat or microwave the products, 
nor to use near an open flame, add to hot water, or put in any 
container in which water is being heated (with an exception for adding 
a steam inhalation product to cold water only in a hot steam 
vaporizer). Potential benefits include a reduction in the number of 
flash fires and serious burns that may occur if consumers should misuse 
these products.
    This final rule will require relabeling of topical/inhalant 
products that contain camphor, menthol, or both ingredients. The 
agency's Drug Listing System identifies about 30 manufacturers and 80 
marketers of over 100 stockkeeping units (SKU's) (individual products, 
packages, and sizes) of topical/inhalant antitussive drug products 
containing camphor, menthol, or both ingredients. There may be a few 
additional marketers and products that are not identified in the 
sources FDA reviewed.
    The agency indicated in the proposal that relabeling costs of the 
type required by this final rule generally average about $2,000 to 
$3,000 per SKU. In determining this cost, the agency did not believe 
that manufacturers would need to increase the package size to add the 
additional labeling information. Almost all of these products are 
marketed in an outer carton, which should have adequate space for the 
additional information. Assuming that there are about 110 affected OTC 
SKU's in the marketplace, FDA estimated that the rule would impose 
total one-time compliance costs on industry for

[[Page 46867]]

relabeling of about $220,000 to $330,000. The agency did not receive 
any comments on these estimates.
    The agency believes the actual cost could be lower for several 
reasons. First, most of the label changes will be made by private label 
small manufacturers that tend to use simpler and less expensive 
labeling. However, the final rule will not require any new reporting 
and recordkeeping activities. Therefore, no additional professional 
skills are needed. Second, the agency has made the compliance dates for 
this final rule the same as the dates for these monographed products to 
be in compliance with the new standardized format and standardized 
content requirements for the labeling of OTC drug products 
(Sec. 201.66), which are now May 16, 2002 (and May 16, 2003, for 
products with annual sales less than $25,000). Manufacturers will not 
incur any expenses determining how to state the product's labeling. All 
manufacturers should have ample time to use up existing labeling stocks 
and the relabeling costs would be mitigated. Thus, all required 
labeling changes can be made at the same time, thereby reducing the 
labeling cost of this final rule.
    The agency considered but rejected several labeling alternatives: 
(1) A shorter or longer implementation period, and (2) an exemption 
from coverage for small entities. While the agency believes that 
consumers would benefit from having this new labeling in place as soon 
as possible, the agency also acknowledges that coordination of this 
labeling change with implementation of the new OTC ``Drug Facts'' 
labeling may significantly reduce the costs of this final rule. Both a 
shorter and a longer time period for this rule may cost more if firms 
would have to undertake two successive labeling revisions. In addition, 
a longer time period would unnecessarily delay the benefit of the new 
labeling to consumers who self-medicate with these products. The agency 
rejected an exemption for small entities because the new labeling 
information is also needed by consumers who purchase products marketed 
by those entities.
    The agency does not believe that this final rule will have a 
significant economic impact on small entities, using the U.S. Small 
Business Administration designations for this industry (750 employees). 
The agency believes that any other unidentified manufacturer of these 
products is also a small entity. From information available to the 
agency, it appears that only one small entity manufactures more than 
three SKU's of these products. Based on the limited number of SKU's 
each manufacturer has to relabel, the cost for each manufacturer except 
one should be minimal.
    Under the Unfunded Mandates Reform Act, FDA is not required to 
prepare a statement of costs and benefits for this final rule because 
this rule is not expected to result in any 1-year expenditure that 
would exceed $100 million adjusted for inflation.
    This analysis shows that the agency has considered the burden to 
small entities. Thus, this economic analysis, together with other 
relevant sections of this document, serves as the agency's final 
regulatory flexibility analysis, as required under the Regulatory 
Flexibility Act.

VI. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirements in this final rule are 
not subject to review by the Office of Management and Budget because 
they do not constitute a ``collection of information'' under the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Rather, the 
labeling requirements are a ``public disclosure of information 
originally supplied by the Federal Government to the recipient for the 
purpose of disclosure to the public'' (5 CFR 1320.3(c)(2)).

VII. Environmental Impact

    The agency has determined under 21 CFR 25.31(a) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

List of Subjects

21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 341

    Labeling, Over-the-counter drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
201 and 341 are amended as follows:

PART 201--LABELING

    1. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.

    2. Section 201.66 is amended by revising paragraph (c)(5)(ii)(C) to 
read as follows:


Sec. 201.66  Format and content requirements for over-the-counter (OTC) 
drug product labeling.

* * * * *
    (c) * * *
    (5) * * *
    (ii) * * *
    (C) Flammability warning, with appropriate flammability signal 
word(s) (e.g., Secs. 341.74(c)(5)(iii), 358.150(c), and 358.550(c) of 
this chapter). This warning shall follow a subheading containing the 
appropriate flammability signal word(s) described in an applicable OTC 
drug monograph or approved drug application.
* * * * *

PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC 
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

    3. The authority citation for 21 CFR part 341 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

    4. Section 341.74 is amended by adding new paragraphs (c)(5)(iii) 
through (c)(5)(vii), and by revising paragraphs (d)(2)(i), (d)(2)(ii), 
(d)(2)(iv), and (d)(2)(v) to read as follows:


Sec. 341.74  Labeling of antitussive drug products.

* * * * *
    (c) * * *
    (5) * * *
    (iii) For any product containing camphor or menthol in a suitable 
ointment vehicle or for steam inhalation use and meets the definition 
of one of the signal words (``extremely flammable,'' ``flammable,'' 
``combustible'') as described in 16 CFR 1500.3(b)(10). The labeling 
contains the appropriate flammability signal word(s) followed by a 
colon and the statement ``Keep away from fire or flame.''
    (iv) For any product containing camphor or menthol in a suitable 
ointment vehicle and that does not contain a flammability signal word 
as described in 16 CFR 1500.3(b)(10). ``When using this product, do not 
[bullet] \1\ heat [bullet] microwave [bullet] add to hot water or any 
container where heating water. May cause splattering and result in 
burns.'' [Information highlighted in bold type.]
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    \1\ For a definition of the term ``bullet,'' see 
Sec. 201.66(b)(4) of this chapter.
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    (v) For any product containing camphor or menthol in a suitable 
ointment vehicle and that contains a flammability signal word as 
described in 16 CFR 1500.3(b)(10). ``When using this

[[Page 46868]]

product, do not [bullet] heat [bullet] microwave [bullet] use near an 
open flame [bullet] add to hot water or any container where heating 
water. May cause splattering and result in burns.'' [Information 
highlighted in bold type.]
    (vi) For any product containing camphor or menthol for steam 
inhalation use. ``When using this product, do not [bullet] heat 
[bullet] microwave [bullet] use near an open flame [bullet] add to hot 
water or any container where heating water except when adding to cold 
water only in a hot steam vaporizer. May cause splattering and result 
in burns.'' [Information highlighted in bold type.]
    (vii) For any product formulated in a volatile vehicle. The 
labeling contains the following statement under the heading ``Other 
information'': ``Close container tightly and store at room temperature 
away from heat.''
    (d) * * *
    (2) * * *
    (i) For products containing camphor identified in Sec. 341.14(b)(1) 
in a suitable ointment vehicle. The product contains 4.7 to 5.3 percent 
camphor. ``[bullet] see important warnings under `When using this 
product' '' [appears as the first statement under the heading 
``Directions'' and is highlighted in bold type] [bullet] adults and 
children 2 years and older: [bullet] rub on the throat and chest in a 
thick layer [bullet] cover with a warm, dry cloth if desired [bullet] 
clothing should be loose about throat and chest to help vapors reach 
the nose and mouth [bullet] use up to three times daily or as directed 
by a doctor [bullet] children under 2 years of age: Ask a doctor.
    (ii) For products containing menthol identified in 
Sec. 341.14(b)(2) in a suitable ointment vehicle. The product contains 
2.6 to 2.8 percent menthol. ``[bullet] see important warnings under 
`When using this product' '' [appears as the first statement under the 
heading ``Directions'' and is highlighted in bold type] [bullet] adults 
and children 2 years and older: [bullet] rub on the throat and chest in 
a thick layer [bullet] cover with a warm, dry cloth if desired [bullet] 
clothing should be loose about throat and chest to help vapors reach 
the nose and mouth [bullet] use up to three times daily or as directed 
by a doctor [bullet] children under 2 years of age: Ask a doctor.
* * * * *
    (iv) For products containing camphor identified in 
Sec. 341.14(b)(1) for steam inhalation use. The product contains 6.2 
percent camphor. ``[bullet] see important warnings under `When using 
this product' '' [appears as the first statement under the heading 
``Directions'' and is highlighted in bold type] [bullet] adults and 
children 2 years and older: (select one of the following, as 
appropriate: For products formulated to be added directly to cold water 
inside a hot steam vaporizer. [bullet] use 1 tablespoonful of solution 
for each quart of water or 1\1/2\ teaspoonsful of solution for each 
pint of water [bullet] add solution directly to cold water only in a 
hot steam vaporizer [bullet] follow manufacturer's directions for using 
vaporizer or For products formulated to be placed in the medication 
chamber of a hot steam vaporizer. [bullet] place water in the vaporizer 
and follow manufacturer's directions for using vaporizer [bullet] place 
solution in the medication chamber only) [bullet] breathe in the 
medicated vapors [bullet] use up to three times daily or as directed by 
a doctor [bullet] children under 2 years of age: Ask a doctor.
    (v) For products containing menthol identified in Sec. 341.14(b)(2) 
for steam inhalation use. The product contains 3.2 percent menthol. 
``[bullet] see important warnings under `When using this product' 
''[appears as the first statement under the heading ``Directions'' and 
is highlighted in bold type] [bullet] adults and children 2 years and 
older: (select one of the following, as appropriate: For products 
formulated to be added directly to cold water inside a hot steam 
vaporizer. [bullet] use 1 tablespoonful of solution for each quart of 
water or 1\1/2\ teaspoonsful of solution for each pint of water 
[bullet] add solution directly to cold water only in a hot steam 
vaporizer [bullet] follow manufacturer's directions for using vaporizer 
or For products formulated to be placed in the medication chamber of a 
hot steam vaporizer. [bullet] place water in the vaporizer and follow 
manufacturer's directions for using vaporizer [bullet] place solution 
in the medication chamber only) [bullet] breathe in the medicated 
vapors [bullet] use up to three times daily or as directed by a doctor 
[bullet] children under 2 years of age: Ask a doctor.
* * * * *

    Dated: July 21, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-19302 Filed 7-31-00; 8:45 am]
BILLING CODE 4160-01-F