Label: AUDIOLOGISTS CHOICE EARWAX REMOVAL AID DROPS- carbamide peroxide solution/ drops
- NDC Code(s): 59256-836-34
- Packager: Oaktree Products Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 14, 2023
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- Drug Facts
- Active ingredient
- Uses
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Warnings
For use in the ear only
Ask a doctor before use if you have
- ear drainage or discharge
- ear pain
- irritation, or rash in the ear
- dizziness
- an injury or perforation (hole) of the ear drum
- recently had ear surgery
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Directions
FOR USE IN THE EAR ONLY
Adult and children over 12 years of age:
- Tilt head sideways and place 5 to 10 drops into ear
- Tip of applicator should not enter ear canal
- Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
- Use twice daily for up to 4 days if needed, or as directed by a doctor
- Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe
Children under 12 years: consult a doctor
- Other information
- Inactive ingredients
- Questions?
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
AUDIOLOGISTS CHOICE EARWAX REMOVAL AID DROPS
carbamide peroxide solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59256-836 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 65 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM LAURYL SULFATE (UNII: 368GB5141J) WATER (UNII: 059QF0KO0R) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59256-836-34 1 in 1 CARTON 06/01/2016 1 15 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M014 06/01/2016 Labeler - Oaktree Products Inc (800748329) Establishment Name Address ID/FEI Business Operations Bell Pharmaceuticals, Inc. 140653770 manufacture(59256-836)