Label: BIO-GROOM- boric acid and salicylic acid solution
- NDC Code(s): 46521-003-01, 46521-003-04, 46521-003-08, 46521-003-28
- Packager: Bio-Derm Laboratories Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 10, 2011
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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Warnings
For external use only on dogs and cats
Ask a veterinarian before use if your pet has
- painful ear condition
- discharge
- broken or abraded skin
When Using this product
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
- Directions
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 3.8L Bottle Label
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INGREDIENTS AND APPEARANCE
BIO-GROOM EAR-CARE
boric acid and salicylic acid solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46521-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID 0.8 mg in 100 mL SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.2 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLYSORBATE 60 (UNII: CAL22UVI4M) EUCALYPTOL (UNII: RV6J6604TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46521-003-04 118 mL in 1 BOTTLE 2 NDC:46521-003-08 236 mL in 1 BOTTLE 3 NDC:46521-003-01 29 mL in 1 BOTTLE 4 NDC:46521-003-28 3800 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 06/10/1985 Labeler - Bio-Derm Laboratories Inc. (057405219) Establishment Name Address ID/FEI Business Operations Bio-Derm Laboratories Inc. 057405219 MANUFACTURE