Otix Ear wax Removal System Ear wax and Bulb

Otix Ear wax Removal System Ear wax and Bulb is an FDA drug label for the active ingredient CARBAMIDE PEROXIDE manufactured by Bell Pharmaceuticals, Inc.. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231214.

Generic: CARBAMIDE PEROXIDE

Manufacturer: Bell Pharmaceuticals, Inc.

Product Type: HUMAN OTC DRUG

Route:

Dosage Form:

NDC: 15579-839

Application: M014

Effective: 20231214

Active Ingredients: Active ingredient Carbamide peroxide 6.5% Purpose Earwax removal aid

Indications & Usage

Uses for occasional use as an aid to soften, loosen, and remove excessive earwax

Dosage & Administration

Directions FOR USE IN THE 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 ear syringe Children Under 12 years: consult a doctor

Contraindications

Not available.

Warnings

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 When using this product avoid contact with the eyes Stop use and ask a doctor if you need to use for more than 4 days excessive earwax remains after use of this product Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Not available.

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