Label: GNC PETS ITCH RELIEF (PREMIUM FORMULA)- pramoxine hydrochloride, hydrocortisone, and lidocaine hydrochloride shampoo

  • NDC Code(s): 43655-000-01, 43655-000-02
  • Packager: General Nutrition Corporation
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Updated November 5, 2018

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  • SPL UNCLASSIFIED SECTION

    342000
    IMG

  • INDICATIONS & USAGE

    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 well. Repeat as needed.

  • SPL UNCLASSIFIED SECTION

    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.

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

    For maximum relief, follow with GNC Pets Itch Relief Medicated Conditioner to speed the relief of symptoms.

  • SPL UNCLASSIFIED SECTION

    Active Ingredients:
    Pramoxine HCL0.25%
    Hydrocortisone0.05%
    Lidocaine HCL0.05%
  • SPL UNCLASSIFIED SECTION

    Other Ingredients: Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Sodium Lactate, Glycerin, Retinyl Palmitate, Panthenol, Aloe Barbadensis Leaf Juice, Pramoxine HCL, Styrene/Acrylates Copolymer, Hydrocortisone, Lidocaine HCL, Fragrance, DMDM Hydantoin, Caramel, Blue 1.

  • SPL UNCLASSIFIED SECTION

    For more information: 1-888-612-1198

    SHOP NOW @ PETSMART.COM

    Distributed by:
    General Nutrition Corporation
    Pittsburgh, PA 15222

  • PRINCIPAL DISPLAY PANEL - 503 ML Bottle Label

    MEDICATED+
    ITCH RELIEF
    SHAMPOO

    PREMIUM FORMULA

    GNC
    PETS

    S
    MEDICATED
    SHAMPOO

    Relieves itching, scratching
    and redness

    With hydrocortisone to
    calm irritated skin

    • MEDICATED CARE
    +
    • MEDICATED CARE

    EUCALYPTUS SCENT
    NET WT. 17 OZ (503 ML)

    PRINCIPAL DISPLAY PANEL - 503 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    GNC PETS ITCH RELIEF (PREMIUM FORMULA) 
    pramoxine hydrochloride, hydrocortisone, and lidocaine hydrochloride shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:43655-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride2.5 mg  in 1 mL
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone0.5 mg  in 1 mL
    Lidocaine Hydrochloride (UNII: V13007Z41A) (Lidocaine - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Decyl Glucoside (UNII: Z17H97EA6Y)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Panthenol (UNII: WV9CM0O67Z)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Caramel (UNII: T9D99G2B1R)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43655-000-01503 mL in 1 BOTTLE, PLASTIC
    2NDC:43655-000-02946 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/30/2012
    Labeler - General Nutrition Corporation (014960165)
    Establishment
    NameAddressID/FEIBusiness Operations
    Marianna Industries, Inc045570736MANUFACTURE, API MANUFACTURE
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