PRAMOX-1- pramoxine hcl spray

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

Temporary relief of itching, flaking, and irritation.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF THE REACH OF CHILDREN

INDICATIONS & USAGE

Pramox-1™ Spray is a soothing and moisturizing formulation for dogs, cats and horses, containing pramoxine and micronized colloidal oatmeal for the temporary relief of itching, flaking, and irritation. It also contains coat conditioners and Omega-6 Essential Fatty Acids to nourish the skin and help further control irritation. Pramox-1™ Spray is formulated in a moistening base for a long-lasting soothing effect. The alcohol-free formulation may be sprayed directly onto the irritated or raw areas to relieve itching.

DOSAGE & ADMINISTRATION

Directions for Use: Shake well before use. Spray directly onto affected skin area(s). If necessary, ruffle or part the hair to allow direct contact with the skin. Rub in well. May be used daily or as directed by 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 eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

STORAGE AND HANDLING

Storage: Store at controlled room temperature.

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerine, Silicone Emulsion, Polysorbate 20, Stearamidopropyl Dimethylamine Lactate, Carthamus Tinctorius (Safflower) Seed Oil, Sodium Lactate, PEG-75 Lanolin, Hydrolyzed Oats, Fragrance, Methylisothiazolinone.

SPL UNCLASSIFIED SECTION

Formulated for Dogs, Cats & Horses

Provides soothing relief from itching, flaking and irritation.

FOR VETERINARY USE ONLY

Tropical Scent

​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 spray

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86069-108
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)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
STEARAMIDOPROPYL DIMETHYLAMINE LACTATE (UNII: 31Q9363QSX)
SAFFLOWER OIL (UNII: 65UEH262IS)
SODIUM LACTATE (UNII: TU7HW0W0QT)
PEG-75 LANOLIN (UNII: 09179OX7TB)
OAT (UNII: Z6J799EAJK)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86069-108-08	237 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)