GLENHAVEN BENASOOTHE- pramoxine hydrochloride and diphenhydramine hydrochloride shampoo

GlenHaven Benasoothe by

Drug Labeling and Warnings

GlenHaven Benasoothe by is a Animal medication manufactured, distributed, or labeled by GlenHaven LLC, Dechra Veterinary Products. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VETERINARY INDICATIONS

Benasoothe Shampoo is a moisturizing shampoo which promotes relief of itchy, irritated skin in cats and dogs. Ceramides aid in moisturizing, repairing, and restoring dry, damaged skin.

DESCRIPTION

ACTIVE INGREDIENTS: 1% Pramoxine HCL USP, 1% Diphenhydramine HCL USP

SPL UNCLASSIFIED SECTION

ALSO CONTAINS: Water, Sodium C14-16 Alpha Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Sodium Laureth Sulfate, Glycol Stearate, Fragrance, Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Cocos Nucifera (Coconut) Oil, Sodium Chloride, Methylchloroisothiazolinone, Methylisothiazolinone

DOSAGE & ADMINISTRATION

DIRECTIONS: Shake well before use. Apply to wet coat, and massage into coat to create a lather. Wait 5-10 minutes, then rinse well. Use daily or as directed by your veterinarian. For best results, follow with Glenhaven Benasoothe Conditioner after bathing and between baths to soothe irritated skin.

WARNINGS

CAUTION: For topical use only. Avoid contact with eyes. If skin irritation develops or increases, stop use and call your veterinarian. Keep out of the reach of children and pets. Wash hands after use.

HOW SUPPLIED

STORAGE: Store at controlled room temperature of 20-25° C (68-77° F).

SPL UNCLASSIFIED SECTION

Available through licensed veterinarians only.

Manufactured for:
GlenHaven
PO Box 13998
8000 NE Tillamook St.
Portland, OR 97213

53243 REV01/17

PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label

NDC: 70782-201-12

GlenHaven™
Therapeutics

Medically Formulated

Benasoothe
Shampoo

New Improved Formulation
Formerly A2/S

Soothing,
relieves itching

Pramoxine HCL,
diphenhydramine HCL

For Dog and Cat Use Only

Net Contents: 12 FL OZ. (355 mL)

INGREDIENTS AND APPEARANCE

GLENHAVEN BENASOOTHE 
pramoxine hydrochloride and diphenhydramine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 70782-201
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
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	10 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70782-201-12	355 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/01/2016

Labeler - GlenHaven LLC (002542300)

Registrant - Dechra Veterinary Products (362142734)