Otc - Active Ingredient
Carbamide Peroxide 6.5%
Harris Teeter Earwax Removal Drops Liquid
FDA Label NDC 69256-117
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Harris Teeter Llc for the product Harris Teeter Earwax Removal Drops (NDC 69256-117). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Earwax removal aid
Indications & Usage
For occasional use as an aid to soften, loosen, and remove excessive earwax.
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) of the eardrum 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 the eyes. If accidental contact with the eyes occurs, flush your eyes with water and consult a doctor.
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
FOR IN EAR USE 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 of age: consult a doctor.
Inactive Ingredient
Citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid.
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