FDA Label for Ero Ear Wax Removal Kit
View Indications, Usage & Precautions
Ero Ear Wax Removal Kit Product Label
The following document was submitted to the FDA by the labeler of this product Randob Labs. 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.
Otc - Active Ingredient
Carbamide Peroxide 6.5%
Otc - Purpose
Earwax removal aid
Indications & Usage
For occasional use as an aid to soften, loosen, and remove excessive earwax.
Warnings
Ask a doctor before use if you have
- if you have ear drainage or discharge, ear pain, irritation or rash in the ear, dizziness
- an injury or perforation (hole) of the eardrum, recently had ear surgery
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, excessive earwax remains after use of this product.
Otc - Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
FOR IN EAR USE 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
Aloe Barbadensis Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid.
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