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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Drug Label Information
Updated November 5, 2018
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- SPL UNCLASSIFIED SECTION
- Directions for Use:
- SAFE HANDLING WARNING
- SPL UNCLASSIFIED SECTION
- DESCRIPTION
- For More Information:
- PRINCIPAL DISPLAY PANEL - 300 mL Bottle Label
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INGREDIENTS AND APPEARANCE
GNC PETS HOT SPOT (PREMIUM FORMULA)
diphenhydramine hydrochloride, hydrocortisone, and benzethonium chloride sprayProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:43655-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 5 mg in 1 mL Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 0.5 mg in 1 mL Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43655-002-01 503 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/30/2012 Labeler - General Nutrition Corporation (014960165) Establishment Name Address ID/FEI Business Operations Marianna Industries, Inc 045570736 MANUFACTURE, API MANUFACTURE