Active Ingredient
Carbamide Peroxide USP 6.5%
Earclearrx
FDA Label NDC 74318-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nuance Medical, Llc for the product Earclearrx (NDC 74318-102). 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 active ingredient, otc - purpose, warnings, otc - keep out of reach of children, directions, inactive ingredients, other, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
For occasional use as an aid to soften, loosen, and remove excessive earwax.
Warnings
Ask a doctor before use if you have ear drainage, discharge, ear pain, irritation or rash in the ear, dizziness, had an injury or perforation of the ear drum. When using this product avoid contact with the eyes. Stop use and ask a doctor if you need to use for more than four days.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222).
Directions
FOR USE IN THE EAR ONLY. Tilt head sideways, place 5-10 drops in the ear, tip of the applicator should not enter the ear canal. Keep drops in the ear for several minutes by keeping head tilted or placing cotton in the ear. Use twice daily for up to four 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 an ear irrigation system.
Inactive Ingredients
Glycerin, Propylene Glycol, Sodium Bicarbonate, Lactic Acid, Purified Water
Other
Children under 12 years of age: consult a doctor before use.
Distributed by: Nuance Medical LLC
Other Information
Do not store above 25°C (77°F).
Question Or Comments
(760) 362-8411
Principal Display Panel - 15 Ml Bottle Label
EARCLEAR Rx™
EAR WAX
REMOVAL
DROPS
Active ingredients:
Carbamide Peroxide USP 6.5%
0.5 FL OZ (15 mL)
NDC: 74318-102-05
Principal Display Panel (15 mL Bottle Label)
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