PRAMOX-1- pramoxine hcl shampoo

Pramox-1 by

Drug Labeling and Warnings

Pramox-1 by is a Animal medication manufactured, distributed, or labeled by Stratford Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Pramoxine HCL, 1%

PURPOSE

Soothing shampoo for cleansing of the hair coat, and temporary relief of itching, flaking and irritation.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN

INDICATIONS & USAGE

Pramox-1™ Shampoo is a gentle cleansing formulation for dogs, cats and horses. Pramox-1™ Shampoo contains pramoxine and micronized colloidal oatmeal for the temporary relief of itching, flaking, and irritation. The soap-free formulation also contains Omega-6 Essential Fatty Acids to nourish the skin and help further control of irritation.

DOSAGE & ADMINISTRATION

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

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.

STORAGE AND HANDLING

Storage: Store at controlled room temperature.

SPL UNCLASSIFIED SECTION

Formulated for Dogs, Cats & Horses

Soothing shampoo for cleansing of the hair coat, and temporary relief of itching, flaking and irritation.

FOR VETERINARY USE ONLY

Available Through Licensed Veterinarians Only.

Manufactured for:
Stratford Pharmaceuticals
Oldsmar, FL 34677
877-498-2002
www.stratfordrx.com

Packaging

INGREDIENTS AND APPEARANCE

PRAMOX-1 
pramoxine hcl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86069-109
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)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
OATMEAL (UNII: 8PI54V663Y)
GLYCERIN (UNII: PDC6A3C0OX)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86069-109-12	355 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/11/2011

Labeler - Stratford Pharmaceuticals (057726733)