Label: GNC PETS HOT SPOT (PREMIUM FORMULA)- diphenhydramine hydrochloride, hydrocortisone, and benzethonium chloride spray

  • NDC Code(s): 43655-002-01
  • 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

    342002
    FNG

  • Directions for Use:

    Hold bottle 8 to 10 inches from coat and spray onto affected area.

  • SAFE HANDLING WARNING

    For external use only. Safe for dogs 12 weeks of age and older. Avoid contact with eyes. In case of eye contact, flush thoroughly with water. If condition persists more than 7 days, consult your veterinarian.

  • SPL UNCLASSIFIED SECTION

    Keep out of reach of children and pets.

  • DESCRIPTION

    Active Ingredients:
    Diphenhydramine Hydrochloride0.50%
    Hydrocortisone0.05%
    Benzethonium Chloride0.05%

    Other Ingredients: Water, Alcohol, Glycerin, Sucrose, Polysorbate 20, Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Thiamine Hydrochloride, Cyanocobalamin, DMDM Hydantoin.

  • For More Information:

    1-888-612-1198

    SHOP NOW @ PETSMART.COM

    Distributed by:
    General Nutrition Corporation
    Pittsburgh, PA 15222

  • PRINCIPAL DISPLAY PANEL - 300 mL Bottle Label

    MEDICATED +
    HOT SPOT
    SPRAY

    GNC
    PETS

    PREMIUM FORMULA

    S
    MEDICATED
    SPRAY

    Relieves discomfort
    associated with hot spots

    Helps reduce itching,
    swelling and redness

    Contains ingredients to
    help reduce infection

    • MEDICATED CARE
    +
    • MEDICATED CARE

    UNSCENTED
    Net Wt. 10.14 fl oz
    (300 mL)

    PRINCIPAL DISPLAY PANEL - 300 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    GNC PETS HOT SPOT (PREMIUM FORMULA) 
    diphenhydramine hydrochloride, hydrocortisone, and benzethonium chloride spray
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:43655-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride5 mg  in 1 mL
    Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone0.5 mg  in 1 mL
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sucrose (UNII: C151H8M554)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Panthenol (UNII: WV9CM0O67Z)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
    Thiamine Hydrochloride (UNII: M572600E5P)  
    Cyanocobalamin (UNII: P6YC3EG204)  
    DMDM Hydantoin (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43655-002-01503 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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