FDA Label for Tilcare
View Indications, Usage & Precautions
Tilcare Product Label
The following document was submitted to the FDA by the labeler of this product Tilco Trading Pte. Ltd.. 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.
Drug Facts
Active Ingredient
Carbamide peroxide 6.5%
Purpose
Earwax removal aid
Use
for occasional use as an aid to soften, loosen and remove excessive earwax.
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 ear drum or after ear surgery unless directed by a doctor.
• for more than four days.
When using this product avoid contact with the eyes.
Stop use and ask a doctor if excessive earwax remains after use of this product.
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.
Other Information
• tamper evident: Do not use if outer carton is open, torn or missing.
• store bottle in the outer carton and keep the tip on bottle when not in use
• store at 20-25°C (68-77°F)
• drops foam in contact with earwax due to release of oxygen. You may experience a “crackling” sound
Inactive Ingredients
Glycerin, Lauroyl Sarcosine, Propylene Glycol
Questions?
+1-844-324-5669
You may also report serious side effects to this phone number.
Packaging
* Please review the disclaimer below.