Label: PRAMOXINE HC- pramoxine hydrochloride, hydrocortisone spray
- NDC Code(s): 11695-7220-1
- Packager: Butler Animal Health Supply, LLC dba Covetrus North America
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated April 27, 2020
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DESCRIPTION
Pramoxine HC Spray
ACTIVE INGREDIENTS: Hydrocortisone 1%, pramoxine hydrochloride 1%.
INACTIVE INGREDIENTS: Propylene glycol, water, SD alcohol 40B, glycerin, PEG-75 lanolin, hydrolyzed oats, benzyl alcohol.
PROPERTIES: Pramoxine HC anti-itch spray is a non-stinging formula to help provide relief from itching caused by insect bites, hot spots and other minor skin irritations. Pramoxine hydrochloride is a mild numbing agent. Hydrocortisone, lanolin and oatmeal soothe irritated skin.
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INDICATIONS & USAGE
INDICATIONS: For use on dogs, cats, or horses only. For the temporary relief of pruritus and skin irritations.
DIRECTIONS FOR USE: Shake well before use. Apply on dry fur 1-3 times per day for 2-3 weeks or as directed by your veterinarian. Part the fur and spray directly on the affected area(s) of the skin. Gently smooth product on to the skin to ensure full coverage. Do not allow the animal to lick the treated area.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
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INGREDIENTS AND APPEARANCE
PRAMOXINE HC
pramoxine hydrochloride, hydrocortisone sprayProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7220 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) PEG-75 LANOLIN (UNII: 09179OX7TB) OATMEAL (UNII: 8PI54V663Y) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZYL ALCOHOL (UNII: LKG8494WBH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7220-1 237 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/27/2020 Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329) Registrant - Ceva Sante Animale (261126049)
