PRAMOX-1- pramoxine hcl shampoo 
Stratford Care Usa, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Pramox-1™ Shampoo

Active Ingredients:

Pramoxine HCL 1%

ANTIPRURITIC

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.

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

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.

Cautions: For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult your veterinarian. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Keep out of the reach of children.

Storage: Store at controlled room temperature.

MEDICATED SHAMPOO

RELIEF OF ITCHING, FLAKING & IRRITATION

FOR DOGS, CATS & HORSES

TROPICAL GUAVA SCENT

Stratford Animal Care
A MEMBER OF THE SWEDENCARE FAMILY

Distributed by:
StratfordCare USA
Odessa, FL 33556
877-498-2002
www.stratfordrx.com

Packaging

Pramox-1-109

PRAMOX-1 
pramoxine hcl shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86069-109
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
OATMEAL (UNII: 8PI54V663Y)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86069-109-12355 mL in 1 BOTTLE, PLASTIC
2NDC:86069-109-013785 mL in 1 BOTTLE, PLASTIC
3NDC:86069-109-16473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/11/2011
Labeler - Stratford Care Usa, Inc. (036650469)

Revised: 11/2022
Document Id: 1c025d80-a9aa-423c-869f-3a5a84d7c91e
Set id: f769d057-89e9-4576-8689-303f6ca6abc2
Version: 9
Effective Time: 20221110
 
Stratford Care Usa, Inc.