Label: EAR CLEANSING- alcohol, lactic acid, benzoic acid, and salicylic acid liquid
- NDC Code(s): 47171-234-04
- Packager: Tomlyn Products, a Division of Vetoquinol USA, Inc.
- Category: OTC ANIMAL DRUG LABEL
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Drug Label Information
Updated December 12, 2022
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- DESCRIPTION
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DOSAGE & ADMINISTRATION
DIRECTIONS: Apply liberally into the ear canal. Massage the base of the ear. Allow pet to shake head. Wipe excess away with a cotton ball. For very dirty ears, apply 2-3 times daily for several days. Do not use longer than 7 consecutive days without consulting a veterinarian. For routine cleaning and maintenance of healthy ears, use 1-2 times weekly, or as often as recommended by your veterinarian. Always apply after swimming.
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
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- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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INGREDIENTS AND APPEARANCE
EAR CLEANSING
alcohol, lactic acid, benzoic acid, and salicylic acid liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:47171-234 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 11.08 mL in 1 mL LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT) LACTIC ACID, UNSPECIFIED FORM 17.6 mg in 1 mL Benzoic Acid (UNII: 8SKN0B0MIM) (Benzoic Acid - UNII:8SKN0B0MIM) Benzoic Acid 1.5 mg in 1 mL Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength Tert-Butyl Alcohol (UNII: MD83SFE959) Brucine Sulfate (UNII: KY7O12XPOQ) Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Aloe Vera Leaf (UNII: ZY81Z83H0X) Docusate Sodium (UNII: F05Q2T2JA0) Glycerin (UNII: PDC6A3C0OX) Benzyl Alcohol (UNII: LKG8494WBH) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47171-234-04 118 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/18/2016 Labeler - Tomlyn Products, a Division of Vetoquinol USA, Inc. (037730194) Registrant - Vetoquinol USA, Inc. (106824209) Establishment Name Address ID/FEI Business Operations Vetoquinol N.-A. INC 202919940 MANUFACTURE Establishment Name Address ID/FEI Business Operations Solvay USA, Inc. 154210488 API MANUFACTURE