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
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated September 15, 2020
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- Active ingredient
Ask a doctor before use if you have
- ear drainage or discharge
- ear pain
- irritation or rash in the ear
- an injury or perforation (hole) of the eardrum
- recently had ear surgery
Stop use and ask a doctor if
- you need to use for more than four days
- excessive ear wax remains after use this product
FOR USE IN THE EAR ONLY.
- Adults and children over 12 years of age:
- tilt head sideways
- place 5 to 10 drops into ear canal.
- 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 four 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 of age: consult a doctor.
- Other information
- Inactive ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL
*COMPARE TO THE ACTIVE INGREDIENT IN DEBROX® DROPS
EAR WAX REMOVAL AID DROPS KIT
Carbamide Peroxide 6.5%
Ear Wax Removal Aid
- Safe & Gentle
- Microfoam Cleansing Action
- 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.
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.
INGREDIENTS AND APPEARANCE
EAR WAX REMOVAL AID DROPS
carbamide peroxide liquid
Product 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 final part344 04/18/2019 Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)