Label: GLENHAVEN BENASOOTHE- pramoxine hydrochloride and diphenhydramine hydrochloride shampoo

  • Category: OTC ANIMAL DRUG LABEL

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.

Drug Label Information

Updated December 9, 2021

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  • 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)

    PRINCIPAL DISPLAY PANEL - 355 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    GLENHAVEN BENASOOTHE 
    pramoxine hydrochloride and diphenhydramine hydrochloride shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:70782-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE10 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70782-201-12355 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other06/01/2016
    Labeler - GlenHaven LLC (002542300)
    Registrant - Dechra Veterinary Products (362142734)