Label: GOODWINOL - benzocaine ointment
- NDC Code(s): 21828-100-02
- Packager: Goodwinol Products Corp
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Veterinary Use Ingredients Directions
For the treatment of Mange of dogs. Practically non-toxic when used as directed.
Contains: Benzocaine 2.05%
Other ingredients: Purified Water, White Petrolatum, Lanolin Anhydrous, Mineral Oil, Sorbitan Sesquioleate, Paraffin Wax, Beeswax, Rotenone, Sodium Bisulfite, Magnesium Sulfate, Quaternium-15, and Tartaric Acid
DIRECTIONS: Apply every 24 hours until absorbed. Exercise care in treatment to avoid getting into the eyes. Mange is difficult to diagnose and often requires prolonged treatment. A veterinarian should be consulted if no improvement is noted within 10 days.
MIX WELL PRIOR TO USE.Close
- Caution Storage
CAUTION: May stain light surfaces. Keep out of reach of children.
Store between 15 degrees - 30 degrees C (59 degrees - 86 degrees F)
Not For Internal Use.
Do Not Get Into Eyes.
- Product Label
Mtd. for Goodwinol Prod. Corp. Pierce, CO 80650
Made in the USA
Net Wt. 16 oz. (454g)
- INGREDIENTS AND APPEARANCE
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:21828-100 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 9.3 g in 454 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) LANOLIN (UNII: 7EV65EAW6H) MINERAL OIL (UNII: T5L8T28FGP) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) PARAFFIN (UNII: I9O0E3H2ZE) YELLOW WAX (UNII: 2ZA36H0S2V) ROTENONE (UNII: 03L9OT429T) SODIUM BISULFITE (UNII: TZX5469Z6I) MAGNESIUM SULFATE (UNII: DE08037SAB) QUATERNIUM-15 (UNII: E40U03LEM0) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:21828-100-02 454 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/10/2008 Labeler - Goodwinol Products Corp (075783191) Registrant - Goodwinol Products Corp (075783191) Establishment Name Address ID/FEI Business Operations Goodwinol Products Corp 075783191 label, repack