GLEN HAVEN BENASOOTHE CONDITIONER- pramoxine hydrochloride and diphenhydramine hydrochloride spray, suspension

Glen Haven Benasoothe Conditioner by

Drug Labeling and Warnings

Glen Haven Benasoothe Conditioner 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 Conditioner is a moisturizing leave-on conditioner 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, Glycerine, PEG-75 Lanolin, Cetearyl Isononanoate, Ceteareth 20, Cetearyl Alcohol, Glyceryl Stearate, Ceteareth 12, Cetyl Palmitate, Fragrance, Ceramide 3, Ceramide 6 II, Ceramide 1, Phytosphingosine, Cholesterol, Sodium Lauroyl Lactylate, Carbomer, Xanthan Gum, Decolorized Aloe Barbadensis (Aloe) Leaf Juice, Carthamus Tinctorius (Safflower) Seed Oil, Methylisothiazolinone

DOSAGE & ADMINISTRATION

DIRECTIONS: Shake bottle before each use. Can be applied to your pet's coat wet or dry. For dry application, apply directly to pet's coat or skin and allow to dry. To apply to a wet coat or after shampooing, remove excess water from your pet's coat and spray the conditioner directly on your pet's skin.

Benasoothe Conditioner can also be used as a dip solution by adding two to four caps of conditioner per gallon of water. Use as often as needed or as directed by your veterinarian.

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

39604 REV10/16

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

NDC: 70782-200-08

GlenHaven™
Therapeutics

Medically Formulated

Benasoothe
Conditioner

New Improved Formulation
Formerly A2/C

Leave-on
formula

Soothing, relieves
itching & flaking

Pramoxine HCL,
diphenhydramine HCL

For Dog and Cat Use Only

Net Contents: 8 FL OZ. (236 mL)

INGREDIENTS AND APPEARANCE

GLEN HAVEN BENASOOTHE CONDITIONER 
pramoxine hydrochloride and diphenhydramine hydrochloride spray, suspension

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 70782-200
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
Cetearyl Isononanoate (UNII: P5O01U99NI)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
CETEARETH-12 (UNII: 7V4MR24V5P)
Cetyl Palmitate (UNII: 5ZA2S6B08X)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
XANTHAN GUM (UNII: TTV12P4NEE)
ALOE (UNII: V5VD430YW9)
SAFFLOWER OIL (UNII: 65UEH262IS)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70782-200-08	236 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)