Label: FURAZONE cream
- NDC Code(s): 17153-340-16
- Packager: Squire Laboratories
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated December 4, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
Furazone
INDICATIONS: For the prevention or treatment of surface bacterial
infections of wounds, burns, and cutaneous ulcers.ADMINISTRATION: Apply directly on the lesion with a spatula or first
place on a piece of gauze. Application of a bandage is optional. This
preparation should be in contact with the lesion for at least 24 hours.
The dressing may be changed several times daily or left on the lesion for
a longer period.CAUTION: In case of deep or puncture wounds or serious burns, use
only as recommended by a veterinarian. If redness, irritation or swelling
persists or increases, discontinue use; reconsult veterinarian. Avoid
exposure to alkaline material and fluorescent lighting. -
Furazone Warnings
“HUMAN WARNING”
CARCINOGENESIS: NITROFURAZONE, THE ACTIVE INGREDIENT OF
FURA-ZONE OINTMENT HAS BEEN SHOWN TO PRODUCE MAMMARY
TUMORS IN RATS AND OVARIAN TUMORS IN MICE. SOME PEOPLE
MAY BE HYPERSENSITIVE TO THIS PRODUCT. EITHER WEAR GLOVES
WHEN APPLYING, OR WASH HANDS AFTERWARDS.STORE AT CONTROLLED ROOM TEMPERATURE, 20-25⁰C (68-77⁰F)
KEEP AWAY FROM EXCESSIVE HEAT OR DIRECT SUNLIGHTDO NOT USE ON HORSES INTENDED FOR HUMAN CONSUMPTION
- Furazone
-
INGREDIENTS AND APPEARANCE
FURAZONE
furazone creamProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17153-340 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NITROFURAZONE (UNII: X8XI70B5Z6) (NITROFURAZONE - UNII:X8XI70B5Z6) NITROFURAZONE 0.000908 kg in 1 kg Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 0.298732 kg in 1 kg POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P) 0.15436 kg in 1 kg Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17153-340-16 .454 kg in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA132427 09/13/1984 Labeler - Squire Laboratories (042761197) Registrant - Squire Laboratories (042761197) Establishment Name Address ID/FEI Business Operations Jinan Jinda Pharmaceutical Chemistry 420595001 api manufacture Establishment Name Address ID/FEI Business Operations Squire Laboratories 042761197 manufacture
