Label: TILCARE- carbamide peroxide solution/ drops
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Contains inactivated NDC Code(s)
NDC Code(s): 73390-101-14, 73390-101-15, 73390-101-20 - Packager: Tilco Trading Pte. Ltd.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 25, 2021
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Use
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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.
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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
- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- Packaging
- Packaging
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INGREDIENTS AND APPEARANCE
TILCARE
carbamide peroxide solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73390-101 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 6.5 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) LAUROYL SARCOSINE (UNII: LIJ19P3L6F) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73390-101-15 1 in 1 BOX 10/23/2019 1 NDC:73390-101-14 15 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:73390-101-20 2 in 1 BOX 12/09/2019 2 NDC:73390-101-14 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part344 10/23/2019 Labeler - Tilco Trading Pte. Ltd. (659506330)