Otc - Active Ingredient
Carbamide Peroxide 6.5%
Ear Drops Liquid
FDA Label NDC 0904-6627
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Ear Drops (NDC 0904-6627). 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, dosage & administration, inactive ingredient, otc - keep out of reach of children, 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
Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery
When using this product avoid contact with eyes
Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product
Stop use and ask a doctor if you need to use for more than four days • excessive earwax remains after use of this product
Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions- For use in the ear 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, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
Major2.jpg (Major2)
Major (Major)
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