Tilcare
FDA Label NDC 73390-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Tilco Trading Pte. Ltd. for the product Tilcare (NDC 73390-101). 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 drug facts, active ingredient, purpose, use, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Image Description (2box)
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