TILCARE- carbamide peroxide solution/ drops 
Tilco Trading Pte. Ltd.

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.

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Tilcare EARWAX REMOVAL AID EAR DROPS

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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.

Gently Removes Excessive Earwax

Safe & Easy to Use

Dist. by: Tilco Trading PTE. LTD. 491B River Valley Road #15-01, Valley Point, Singapore - 248373
Made in USA
www.tilcare.com / customers@tilcare.com

Carbamide peroxide 6.5%

Packaging

Ear drops

Packaging

image description

TILCARE 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73390-101
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
LAUROYL SARCOSINE (UNII: LIJ19P3L6F)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73390-101-151 in 1 BOX10/23/2019
1NDC:73390-101-1415 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:73390-101-202 in 1 BOX12/09/2019
2NDC:73390-101-1415 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/23/2019
Labeler - Tilco Trading Pte. Ltd. (659506330)

Revised: 1/2021
Document Id: 227b98c4-4a7f-4c25-afa3-dc701883ebc4
Set id: c3067dbd-0fc4-4405-ba1d-fe09010bf89e
Version: 3
Effective Time: 20210125
 
Tilco Trading Pte. Ltd.