Label: GNC PETS HYPO-ALLERGENIC (PREMIUM FORMULA)- diphenhydramine hydrochloride and hydrocortisone shampoo

  • NDC Code(s): 43655-007-01
  • Packager: General Nutrition Corporation
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 November 1, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    CODE 343061
    APG

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  • DOSAGE & ADMINISTRATION

    Directions for Use: Using warm water, wet coat thoroughly. Apply shampoo from base of neck to the tail, paying special attention to avoid eyes. Gently massage deep into coat and skin. Allow shampoo to remain on pet for up to 5 minutes for maximum benefit. Rinse thoroughly.

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  • SAFE HANDLING WARNING

    For external use only. Safe for dogs 12 weeks of age and older. In case of eye contact, flush thoroughly with water. If condition persists more than 7 days, consult your veterinarian. Do not use on broken or inflamed skin.

    Keep out of reach of children and pets. Do not use more frequently than once a week.

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  • DESCRIPTION

    Active Ingredients:
    Diphenhydramine Hydrochloride 0.05%
    Hydrocortisone 0.05%

    Other Ingredients: Water, Alpha Olefin Sulphonate, Cocamidopropyl Betaine, Aloe barbadensis Leaf Extract, Camellia sinensis Extract, Colloidal Oat Whole Flour, Chamomile Extract, Glycerin, Panthenol, Ascorbic Acid (Vitamin C), Retinyl Palmitate (Vitamin A), Tocopheryl Acetate (Vitamin E), Sodium Chloride, Potassium Sorbate, Methylisothiazolinone.

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  • SPL UNCLASSIFIED SECTION

    For More Information:
    1-888-612-1198

    SHOP NOW @ PETSMART.COM

    Distributed by:
    General Nutrition Corporation
    Pittsburgh, PA 15222

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  • PRINCIPAL DISPLAY PANEL - 502 mL Bottle Label

    MEDICATED +
    HYPO-
    ALLERGENIC
    SHAMPOO
    PREMIUM FORMULA

    GNC
    PETS®

    S
    MEDICATED
    SHAMPOO

    Soothes itchy, red,
    irritated skin

    Fragrance & dye free

    • MEDICATED CARE
    +
    • MEDICATED CARE

    Fragrance Free
    Net Contents 17 fl oz (502 mL)

    PRINCIPAL DISPLAY PANEL - 502 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    GNC PETS HYPO-ALLERGENIC (PREMIUM FORMULA) 
    diphenhydramine hydrochloride and hydrocortisone shampoo
    Product Information
    Product Type OTC ANIMAL DRUG Item Code (Source) NDC:43655-007
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 0.5 mg  in 1 mL
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    C24-28 Olefin (UNII: 6P4501CWYB)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Camellia Sinensis Root (UNII: 8H54O0V2K3)  
    Oatmeal (UNII: 8PI54V663Y)  
    Chamomile (UNII: FGL3685T2X)  
    Glycerin (UNII: PDC6A3C0OX)  
    Panthenol (UNII: WV9CM0O67Z)  
    Ascorbic Acid (UNII: PQ6CK8PD0R)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:43655-007-01 502 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 03/25/2013 01/01/2020
    Labeler - General Nutrition Corporation (014960165)
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