Inactive Ingredient
Citric Acid
Flavor
Glycerin
Propylene Glycol
Sodium Lauroyl Sarcosinate
Sodium Stannate
Purified Water
Earwax Removal Drops Liquid
FDA Label NDC 0395-9133
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Humco Holding Group, Inc for the product Earwax Removal Drops (NDC 0395-9133). 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 inactive ingredient, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, otc - active ingredient, indications & usage, cvs label, 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.
Dosage & Administration
Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Warnings
For External Use Only.
Ask a doctor before use if you have:
Ear drainage or discharge
Ear pain, irritation, or rash in the ear
Recently had ear surgery
Dizziness
An injury or perforation (hole) of the eadrum
Otc - Active Ingredient
Carbamide Peroxide 6.5%
Indications & Usage
For occasional use as an aid to soften, loosen and remove excessive earwax.
Cvs Label
Cvswax.jpg (Cvswax)
Carton (Carton)
Leader Label
Ldrearwax45.jpg (Ldrearwax45)
Ldrewawax90.jpg (Ldrearwax90)
Rite Aid Label
Raearwax45.jpg (Raearwax45)
Raearwax90.jpg (Raearwax90)
Major Label
Majorearwax90.jpg (Majorearwax90)
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