NDC | 17030-234-04, 17030-234-08, 17030-234-10, 17030-234-16 |
Set ID | 2fed6fbd-03b0-43dc-bb7c-9e70a8efc318 |
Category | OTC ANIMAL DRUG LABEL |
Packager | Vetoquinol USA, Inc. |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- VETERINARY INDICATIONS
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
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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 from outer ear 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.
- WARNINGS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 120 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:17030-234 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:17030-234-04 120 mL in 1 BOTTLE, PLASTIC 2 NDC:17030-234-08 237 mL in 1 BOTTLE, PLASTIC 3 NDC:17030-234-16 473 mL in 1 BOTTLE, PLASTIC 4 NDC:17030-234-10 3790 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 12/29/1999 Labeler - 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