Carbamide peroxide 6.5% 65 mg/mL
Earwax Removal Kit · SOLUTION/ DROPS · Allegiant Health
Carbamide peroxide 6.5% is a solution/ drops containing earwax removal kit at 65 mg/mL, taken auricular (otic). Manufactured by Allegiant Health.
Key Facts
- Brand Name
- Carbamide peroxide 6.5%
- Generic Name
- Earwax Removal Kit
- NDC Code (Product)
69168-488- Manufacturer
- Allegiant Health
- Strength
- 65 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- AURICULAR (OTIC)
- Marketing Status
- Application #
- M014
- Marketing Start
- 10/28/2025
Recall History
Pharma Nobis LLC
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Use(s) For occasional use as an aid to soften, loosen and remove excessive earwax.
Dosage & Administration
Directions FOR USE IN EAR ONLY. Adults 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. Children under 12 years of age: consult a doctor
Warnings
Warnings Do not use if you have ear drainage or discharge, ear pain, irritation or rash in the ear or are dizzy; consult a doctor if you have an injury or perforation (hole) in the ear drum or after ear surgery, unless directed by a doctor for more than 4 days; if excessive earwax remains after use of this product, consult a doctor When using this product • avoid contact with eyes. If accidental contact with eyes occurs, flush eyes with water and consult a doctor Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.
Frequently Asked Questions
What is Carbamide peroxide 6.5% used for?
Carbamide peroxide 6.5% contains Earwax Removal Kit. It is a solution/ drops taken auricular (otic). Consult your doctor for specific uses.
Is Carbamide peroxide 6.5% a controlled substance?
Carbamide peroxide 6.5% is not classified as a controlled substance by the DEA.
What is the generic name for Carbamide peroxide 6.5%?
The generic name for Carbamide peroxide 6.5% is Earwax Removal Kit. There are no other listed brand versions of Earwax Removal Kit.
What is the NDC code for Carbamide peroxide 6.5% 65 mg/mL?
The NDC (National Drug Code) for Carbamide peroxide 6.5% 65 mg/mL is 69168-488, listed by Allegiant Health.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)