Ear Wax Removal Aid
FDA Label NDC 49794-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Continental Manufacturing Chemist, Inc. for the product Ear Wax Removal Aid (NDC 49794-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding dosage & administration, warnings, otc - active ingredient, otc - keep out of reach of children, otc - purpose, inactive ingredient, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Dosage & Administration

DIRECTIONS: For use in the ear only. For use by 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 ear.  Use twice daily for up to 4 days, if needed or as directed by a physician.  Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.  For children under 12 years of age, consult a physician.  NOTE: When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.

Warnings

WARNINGS:  DO NOT USE if you have ear drainage or discharge, ear pain, irritation, or rash in the ear, or if you are dizzy; consult a physician.  DO NOT USE if you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a physician.  DO NOT USE for more than 4 days; if excessive earwax remains after use of this product, consult a physician.  Avoid contact with eyes.  If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Active Ingredient

ACTIVE INGREDIENT: Carbamide Peroxide 6.5%

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Otc - Purpose

Softens and removes excessive earwax safely and gently.

Inactive Ingredient

Inactive Ingredient: anhydrous glycerin

Indications & Usage

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

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