Vet Label

Veterinary Product and Label Information

Comfort: Product Information

COMFORT — pramoxine hydrochloride shampoo
Animal Pharmaceuticals

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.

Active Ingredients Purpose

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




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

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 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.

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.

Other Information

  • store at room temperature (59˚F – 86˚F)
  • store in a cool dry place.
MANUFACTURED FOR
Animal Pharmaceuticals
www.anmpharm.com
REV 0812
Item No. 800509 / 801009
PEEL HERE
Comfort SHAMPOO
anmPHARM
Veterinary
CHART TAB
RE-ORDER No. 078715955 / 078715963
SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

anmPHARM
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)
PEEL HERE
Comfort SHAMPOO
anmPHARM
BRING THIS LABEL BACK TO YOUR VET FOR A REFILL16OZ REFILL REMINDER / 128OZ REFILL REMINDER

image of label
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COMFORT pramoxine shampoo
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:68898-106
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68898-106-16 474 mL in 1 BOTTLE, PLASTIC None
2 NDC:68898-106-01 3785 mL in 1 BOTTLE, PLASTIC None
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 Operations
Custom Veterinary Services, Inc. 619511483 manufacture

Revised: 08/2012 Animal Pharmaceuticals