FDA Label for Carbamide Peroxide 6.5%
View Indications, Usage & Precautions
Carbamide Peroxide 6.5% Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant 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.
Active Ingredient(S)
Carbamide peroxide 6.5%
Purpose
Earwax removal aid
Use(S)
For occasional use as an aid to soften, loosen and remove excessive earwax.
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) in the ear drum or after ear surgery, unless directed by a doctor
- for more than 4 days; if excessive earwax remains after use of this product, consult a doctor
When Using This Product
• avoid contact with eyes. If accidental contact with eyes occurs, flush
eyes with water and consult a doctor
Keep Out Of Reach Of Children
If product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
FOR USE IN 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.
Children under 12 years of age: consult a doctor
Other Information
• do not store above 86°F (30°C)
• protect from heat and direct sunlight
• DO NOT USE IF SHRINKBAND ON BOTTLE IS BROKEN OR MISSING
• Product foams on contact with earwax due to the release of oxygen. There may be an associated “crackling” sound.
• Keep cap on bottle when not in use
• Retain carton for full product information.
Inactive Ingredients
citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid
Questions/Comments
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(Monday-Friday 9 AM – 5 PM EST)
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