PRAMOX- pramoxine hydrochloride shampoo

Pramox by

Drug Labeling and Warnings

Pramox 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 Hydrochloride , USP 1%

​Purpose

Topical Anesthetic

​Inactive Ingredients

Water, Sodium C14-16 Olefin Sulfonate, Disodium Cocoamphodiacetate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Sodium Lactate, Hydrolyzed Oats, Carthamus tinctorius (Safflower) Seed Oil, Fragrance, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone.

​Uses:

a medicated shampoo 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 use. Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet hair coat, lather freely. Rinse and repeat. Allow to remain on hair for 5 to 10 minutes, then rinse thoroughly with clean water. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.

​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 Shampoo

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 
pramoxine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 68898-124
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)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LACTATE (UNII: TU7HW0W0QT)
OAT (UNII: Z6J799EAJK)
SAFFLOWER OIL (UNII: 65UEH262IS)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68898-124-16	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)