TILCARE- carbamide peroxide solution/ drops

Tilcare by

Drug Labeling and Warnings

Tilcare by is a Otc medication manufactured, distributed, or labeled by Tilco Trading Pte. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

Packaging

INGREDIENTS AND APPEARANCE

TILCARE 
carbamide peroxide solution/ drops

Product 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)