FDA Label for Ear Wax Removal Aid
View Indications, Usage & Precautions
Ear Wax Removal Aid Product Label
The following document was submitted to the FDA by the labeler of this product Continental Manufacturing Chemist, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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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