Label: KETO-C- chlorhexidine gluconate, ketoconazole shampoo
- NDC Code(s): 86069-100-01, 86069-100-08, 86069-100-12, 86069-100-16
- Packager: Stratford Care Usa, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated November 8, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- STORAGE AND HANDLING
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DOSAGE & ADMINISTRATION
Directions for use: Shake well before use. Wet the coat with warm water and apply a sufficient amount of shampoo to create a rich lather. Massage shampoo into wet coat and work into a lather. Allow to remain on coat for 5 to 10 minutes, then rinse thoroughly with clean water and repeat. May be used initially 2 to 3 times a week for 4 weeks, then reducing to once a week, or as directed by your veterinarian.
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PRECAUTIONS
Cautions: For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult your veterinarian. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Keep out of the reach of children.
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
KETO-C
chlorhexidine gluconate, ketoconazole shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:86069-100 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 2 g in 100 mL KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYACRYLATE-1 CROSSPOLYMER (UNII: R5P9Z5WD6D) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) GLYCOLIC ACID (UNII: 0WT12SX38S) EDETATE SODIUM (UNII: MP1J8420LU) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Product Characteristics Color pink Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86069-100-08 237 mL in 1 BOTTLE, PLASTIC 2 NDC:86069-100-12 355 mL in 1 BOTTLE, PLASTIC 3 NDC:86069-100-16 473 mL in 1 BOTTLE, PLASTIC 4 NDC:86069-100-01 3785 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/11/2011 Labeler - Stratford Care Usa, Inc. (036650469)
