[Title 21 CFR 524.1005]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)]
[Subchapter E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS]
[Part 524 - OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS]
[Sec. 524.1005 - Furazolidone aerosol powder.]
[From the U.S. Government Publishing Office]




  21
  FOOD AND DRUGS
  6
  1996-04-01
  1996-04-01
  false
  
  524.1005
  Sec. 524.1005
  
    FOOD AND DRUGS
    FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
    ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
    OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
  


Sec. 524.1005  Furazolidone aerosol powder.

    (a) Specifications. The product contains either 4 or 10 percent 
furazolidone in inert dispersing agent and propellant.
    (b) Sponsors. (1) See No. 000069 in Sec. 510.600(c) of this chapter 
for use of the 10 percent product as in paragraphs (c)(2) (i) through 
(iii) of this section.
    (2) See No. 017135 for use of the 4 percent product as in paragraph 
(c)(2)(iv) of this section.
    (c) Conditions of use--(1) Amount. Hold container about 6 to 12 
inches from the eye or affected area and apply only enough powder to 
impart a light yellow color.
    (2) Indications of use--(i) Dogs. For treatment or prevention of 
bacterial infection of superficial wounds, abrasions, lacerations, and 
pyogenic dermatitis.
    (ii) Horses. For treatment or prevention of bacterial infection of 
superficial wounds, abrasions, lacerations, and following firing (heat 
or electrocautery).

[[Page 322]]

    (iii) Cattle. For treatment of bacterial infections of the bovine 
eye and for treatment and to reduce the incidence of additional cases of 
infectious bovine keratoconjunctivitis (pink eye) caused by Moraxella 
bovis.
    (iv) Horses and ponies. For treatment or prevention of bacterial 
infection of superficial wounds, abrasions, and lacerations caused by 
Staphylococcus aureus, Streptococcus spp. and Proteus spp. sensitive to 
furazolidone.
    (3) Limitations. For topical application in horses, ponies, and 
dogs: Clean affected area thoroughly, apply drug once or twice daily, 
and repeat treatment as required. For treatment of bacterial infections 
of the bovine eye and infectious bovine keratoconjunctivitis (pink eye) 
caused by Moraxella bovis: Treat affected eyes once daily on each of 3 
to 5 consecutive days; to reduce incidence of additional cases of 
infectious keratoconjunctivitis also medicate unaffected eyes. Evidence 
of clinical improvement of bovine eye infections should be noticeable 
after 5 treatments; if not, reconsult veterinarian. Use only as 
recommended by a veterinarian in treatment of puncture wounds, wounds 
requiring surgical debridement or suturing, those of a chronic nature 
involving proud flesh, generalized and chronic infections of the skin, 
and those skin conditions associated with intense itching. If redness, 
irritation, or swelling persists or increases, discontinue use and 
reconsult veterinarian. Not for use in horses intended for food.

[45 FR 49543, July 25, 1980, as amended at 50 FR 30153, July 24, 1985; 
56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, Nov. 
2, 1995]
Sec. 524.1044  Gentamicin sulfate ophthalmic and topical dosage forms.