Label: EAR WAX REMOVAL AID DROPS- carbamide peroxide liquid
- NDC Code(s): 68016-793-15
- Packager: PHARMACY VALUE ALLIANCE, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 28, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
Ask a doctor before use if you have
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- ear drainage or discharge
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- ear pain
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- irritation or rash in the ear
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- dizziness
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- an injury or perforation (hole) of the eardrum
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- recently had ear surgery
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Directions
FOR USE IN THE EAR ONLY.
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- Adults and children over 12 years of age:
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- tilt head sideways
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- place 5 to 10 drops into ear canal.
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- tip of applicator should not enter ear canal.
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- keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.
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- use twice daily for up to four days if needed, or as directed by a doctor.
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- 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 of age: consult a doctor.
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL
Premier Value®
NDC 68016-793-15
*COMPARE TO THE ACTIVE INGREDIENT IN DEBROX® DROPS
EAR WAX REMOVAL AID DROPS KIT
Carbamide Peroxide 6.5%Ear Wax Removal Aid
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- Safe & Gentle
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- Microfoam Cleansing Action
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- Easy to use Instructions
NET WT 0.5 FL OZ (15 mL)
This kit include soft rubber bulb ear syringe and drops
TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN
IMPORTANT: Keep the carton for future reference on full labeling.
Distributed BY:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, PA 19087
*This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox® Drops.
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INGREDIENTS AND APPEARANCE
EAR WAX REMOVAL AID DROPS
carbamide peroxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-793 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 0.065 mg in 1 mL Inactive Ingredients Ingredient Name Strength ADIPIC ACID (UNII: 76A0JE0FKJ) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-793-15 1 in 1 CARTON 04/18/2019 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 04/18/2019 Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)
