Label: GNC PETS ANTI-BACETERIAL AND ANTI-FUNGAL (PREMIUM FORMULA)- chlorhexidine gluconate and ketoconazole shampoo
- NDC Code(s): 43655-004-01, 43655-004-02
- 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
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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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.
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 Anti-Bacterial & Anti-Fungal Medicated Conditioner to speed the relief of symptoms.
- Active Ingredients:
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SPL UNCLASSIFIED SECTION
Other Ingredients: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Cocamide DEA, Polyacrylate-1 Crosspolymer, Glycerin, Chlorohexidine Gluconate, Tocopheryl Acetate, Ketoconazole, Retinyl Palmitate, Ascorbic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Sodium Lactate, Lactic Acid, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40, Ext. Violet 2.
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- PRINCIPAL DISPLAY PANEL - 503 ml Bottle Label
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INGREDIENTS AND APPEARANCE
GNC PETS ANTI-BACETERIAL AND ANTI-FUNGAL (PREMIUM FORMULA)
chlorhexidine gluconate and ketoconazole shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:43655-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate 10 mg in 1 mL Ketoconazole (UNII: R9400W927I) (Ketoconazole - UNII:R9400W927I) Ketoconazole 2.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Cocamidopropyl Betaine (UNII: 5OCF3O11KX) Coco Diethanolamide (UNII: 92005F972D) Glycerin (UNII: PDC6A3C0OX) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Vitamin A Palmitate (UNII: 1D1K0N0VVC) Ascorbic Acid (UNII: PQ6CK8PD0R) Tea Tree Oil (UNII: VIF565UC2G) Sodium Lactate (UNII: TU7HW0W0QT) LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) Methylchloroisothiazolinone (UNII: DEL7T5QRPN) Methylisothiazolinone (UNII: 229D0E1QFA) FD&C RED NO. 40 (UNII: WZB9127XOA) EXT. D&C VIOLET NO. 2 (UNII: G5UX3K0728) Product Characteristics Color PURPLE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43655-004-01 503 mL in 1 BOTTLE, PLASTIC 2 NDC:43655-004-02 946 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 02/06/2012 Labeler - General Nutrition Corporation (014960165) Establishment Name Address ID/FEI Business Operations Marianna Industries, Inc 045570736 MANUFACTURE, API MANUFACTURE
