PRAMOX CREME RINSE- pramoxine hydrochloride rinse

Pramox Creme rinse by

Drug Labeling and Warnings

Pramox Creme rinse by is a Animal medication manufactured, distributed, or labeled by Animal Pharmaceuticals, Stratford Care Usa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Pramoxine HCl, USP 1%

Purpose

Topical Anesthetic

Inactive Ingredients

Water, Cetearyl Alcohol, PEG-40 Hydrogenated Castor Oil, Stearalkonium Chloride, Hydrolyzed Oats, Hydrolyzed Wheat Protein, Polysorbate-60, Glycerin, Dimethicone, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Hydroxide.

Uses:

a medicated creme rinse for the temporary relief of itching and scratching on dogs, cats and horses with dermatological conditions responsive to pramoxine.

Directions for Use:

Shake well before using. Apply Creme Rinse evenly over and into the hair coat and rub in well. Rinse well and repeat the procedure if desired. May be used as often as necessary.

Precautions

For topical use on animals only. If redness or irritation persists or increases, discontinue use and consult a veterinarian. Avoid contact with the eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.

SPL UNCLASSIFIED SECTION

Anti-itch Creme Rinse

For Temporary Relief Of Dermatological Conditions Responsive To Pramoxine.

Tropical Guava

Formulated for Dogs, Cats & Horses

At Animal Pharmaceuticals we strive to provide the best nutritional and topical treatments for your pet by going above and beyond...and we don't stop there. We know that caring for your pet is just as important as caring for your own health, so we've developed and implemented systems that make things easier on you and convenient for your veterinarian.

OUR ASSURANCE
Animal Pharmaceuticals products are designed with our proprietary technology that helps retrieve and sustain the nutrients and healthful ingredients. Our proprietary formulation enhances the effects of functional ingredients and penetrates the skin and the effective areas to exert the corrective results.

Additionally, and as always, you'll find that all our bottles and containers are made of recyclable plastic. Please help us protect the environment by recycling.

ALL PRODUCTS ARE MADE IN THE U.S.A. 

To learn more about our products, visit:

www.anmpharm.com

SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

MANUFACTURED FOR
Animal Pharmaceuticals

MADE IN THE USA

Packaging

INGREDIENTS AND APPEARANCE

PRAMOX CREME RINSE 
pramoxine hydrochloride rinse

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 68898-122
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88)
OAT (UNII: Z6J799EAJK)
HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) (UNII: J2S07SB0YL)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68898-122-16	474 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/15/2021

Labeler - Animal Pharmaceuticals (166472444)

Registrant - Stratford Care Usa, Inc. (036650469)