FDA Label for Ear Wax Removing Drops Carbamide Peroxide
View Indications, Usage & Precautions
Ear Wax Removing Drops Carbamide Peroxide Product Label
The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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
Active Ingredient
Carbamide Peroxide 6.5%
Otc - Purpose
Purpose
Carbamide Peroxide 6.5%
Indications & Usage
Uses
For occasional use as an aid to soften, loosen, and remove excessive ear wax.
Warnings
Warnings
Do not use: if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult a doctor. If you have an injury or perforation (hole) of the eardrum or after ear surgery, unless directed by a doctor. For more than four consecutive days.
When using this product: avoid contact with the eyes.
Stop use and ask a doctor if: excessive ear wax remains after use of this product for four consecutive days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.
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 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 a soft rubber bulb ear syringe. Children under 12 years of age: consult a doctor.
Inactive Ingredient
Inactive ingredients
Glycerin, Oxyquinoline, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Oil
Package Label.Principal Display Panel
Ear Wax Cleansing Kit
Step 1 Ear Wax Removing Drops
Step 2 Ear Cleansing Spray
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