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

  • NDC Code(s): 43655-003-02
  • Packager: General Nutrition Corporation
  • Category: OTC ANIMAL DRUG LABEL

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Drug Label Information

Updated November 5, 2018

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  • SPL UNCLASSIFIED SECTION

    342003
    IMG

  • DOSAGE & ADMINISTRATION

    Directions for use:

    Apply conditioner liberally from base of neck to the tail, paying special attention to avoid eyes. Work thoroughly through the coat. Allow conditioner to remain on pet for up to 5 minutes for maximum benefit. Rinse well and towel dry.

  • 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.

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

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

  • DESCRIPTION

    Active Ingredients:
    Pramoxine HCL0.25%
    Hydrocortisone0.05%
    Lidocaine HCL0.05%

    Other Ingredients: Water, Cetearyl Alcohol, Glycerin, Cetyltrimethylammonium Chloride, Dimethicone, Retinyl Palmitate, Panthenol, Aloe Barbadensis Leaf Juice, Pramoxine HCL, Polyquaternium-10, Disodium EDTA, Hydrocortisone, Lidocaine HCL, Fragrance, DMDM Hydantoin, 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
    CONDITIONER

    PREMIUM FORMULA

    GNC
    PETS

    C
    MEDICATED
    CONDITIONER

    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 CONDITIONER (PREMIUM FORMULA) 
    pramoxine hydrochloride, hydrocortisone, and lidocaine hydrochloride shampoo
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:43655-003
    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)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cetrimonium Chloride (UNII: UC9PE95IBP)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Panthenol (UNII: WV9CM0O67Z)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Polyquaternium-10 (400 MPA.S at 2%) (UNII: HB1401PQFS)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorBLUEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43655-003-02946 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