COMFORT- pramoxine shampoo

Comfort by

Drug Labeling and Warnings

Comfort by is a Animal medication manufactured, distributed, or labeled by Animal Pharmaceuticals, Custom Veterinary Services, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active IngredientsPurpose

Pramoxine HCl, USP ……. 1% (w/w) ………Topical Anesthetic

PURPOSE

Uses a medicated shampoo for the temporary relief of itching and scratching on dogs, cats and horses w/dermatological conditions responsive to pramoxine.

WARNINGS AND PRECAUTIONS

Warnings

• For Animal Use Only
• Consult your veterinarian before use

Caution: ▪ Do not use in eyes or nose ▪ Not for prolonged use ▪ If redness, irritation, swelling, or pain persists or increases, discontinue use unless directed by your veterinarian

Ask a veterinarian before use if your animal is using any other medications.

When Using this Product

• use only on dogs, cats and horses
• use topically only
• avoid contact with eyes and mucous membranes

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.

DOSAGE & ADMINISTRATION

Directions Wet the hair coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage medicated shampoo into the wet hair coat, lather freely. Allow to remain on hair coat for 5 to 10 minutes, then rinse thoroughly with clean water.

STORAGE AND HANDLING

Other Information

• store at room temperature (59˚F – 86˚F)
• store in a cool dry place.

SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

MANUFACTURED FOR
Animal Pharmaceuticals
www.anmpharm.com  
REV 0614/ REV 0715
Item No. 800509 / 801009

PRINCIPAL DISPLAY PANEL

ANIMAL pharmaceuticals
Comfort SHAMPOO
A Soap Free Anti-Itch Shampoo complemented with Oatmeal and Omega-6 Fatty Acids
Formulated for Dogs, Cats and Horses
16 OZ. (474 mL) / 128 OZ. (3785 mL)

At Animal Pharmaceuticals we strive to provide the best nutrionational 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.

PHARMASOME TECHNOLOGY

Retrieving and sustaining the most nutrients and healthful ingredients is the foundation for this technology. Pharmasomes enhance the effects of the functional ingredients. The nano-sized Pharmasome particles encapsulate functional ingredients, adhere to the surface and penetrate through skin, and thus carry the ingredients to areas where they can exert their effects efficiently. Additionally and as always you'll find that all of our bottles and containers are made of recyclable plastic. Please help us help the environment by recycling.

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INGREDIENTS AND APPEARANCE

COMFORT 
pramoxine shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 68898-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68898-106-16	474 mL in 1 BOTTLE, PLASTIC
2	NDC: 68898-106-01	3785 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2010

Labeler - Animal Pharmaceuticals (166472444)

Registrant - Custom Veterinary Services, Inc. (619511483)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Veterinary Services, Inc.		619511483	manufacture