Otc - Active Ingredient
Active ingredient PurposeCarbamide Peroxide 6.5%..........................Earwax Removal Aid
Cvs Earwax Removal Aid
FDA Label NDC 59779-257
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Cvs Earwax Removal Aid (NDC 59779-257). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Uses for occasional use as an aid to soften, loosen and remove excessive ear wax.
Warnings
Warnings 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 surgeryStop use and ask a doctor if - you need to use for more than four days- excessive wax remains after use of this productWhen using this product - avoid contact with the eyesKeep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
DirectionsFOR USE IN THE EAR ONLYUnscrew cap from bottle. Remove foil safety seal from bottle. Affix applicator cap to bottle.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 ear syringe.Children under 12 years of age: consult a doctor.Other information- avoid exposing the bottle to excessive heat and direct sunlight- keep cap on bottle when not in use- Note: Drops foam on contact with ear wax due to release of oxygen. There may be an associated "cracking" sound- Note: Oversize packaging for ease in reading label information. Contains one bottle.- Store between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)
Inactive Ingredient
Inactive ingredientsglycerin, propylene glycol, purified water, sodium lauroyl sarcosinate, citric acid, flavor, sodium stannate
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