PRAMOXINE HC- pramoxine hydrochloride, hydrocortisone spray

Pramoxine by

Drug Labeling and Warnings

Pramoxine by is a Animal medication manufactured, distributed, or labeled by Butler Animal Health Supply, LLC dba Covetrus North America, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

CAUTIONS: For external use on dogs, cats, and horses only. Avoid contact with the eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.  Wash hands after use.

STORAGE AND HANDLING

STORAGE: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Distributed by: 

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

Questions? (855) 724-3461

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

NDC: 11695-7220-1

Pramoxine HC

Anti-itch Spray

Hydrocortisone 1%

pramoxine hydrochloride 1%

Soothing spray for 

dogs, cats, and horses

For animal use only

Keep out of reach of children

SHAKE WELL BEFORE USE

Net Contents: 8 FL. OZ. (237 mL)

INGREDIENTS AND APPEARANCE

PRAMOXINE  HC
pramoxine hydrochloride, hydrocortisone spray

Product 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)