Tilcare Earwax Removal Aid Ear Drops

Tilcare Earwax Removal Aid Ear Drops
SPL v3
SPL
SPL Set ID c3067dbd-0fc4-4405-ba1d-fe09010bf89e
Route
AURICULAR (OTIC)
Published
Effective Date 2019-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (6.5 g)
Inactive Ingredients
Glycerin Lauroyl Sarcosine Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-10-23

Description

Carbamide peroxide 6.5%

Purpose

Earwax removal aid


Medication Information

Purpose

Earwax removal aid

Description

Carbamide peroxide 6.5%

Use

for occasional use as an aid to soften, loosen and remove excessive earwax.

Section 42229-5

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 / [email protected]

Carbamide peroxide 6.5%

Section 50565-1

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

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.

Packaging

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.

Drug Facts

Questions?

+1-844-324-5669

You may also report serious side effects to this phone number.

Active Ingredient

Carbamide peroxide 6.5%

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


Structured Label Content

Use

for occasional use as an aid to soften, loosen and remove excessive earwax.

Section 42229-5 (42229-5)

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 / [email protected]

Carbamide peroxide 6.5%

Section 50565-1 (50565-1)

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

Purpose

Earwax removal aid

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.

Packaging

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.

Drug Facts

Questions?

+1-844-324-5669

You may also report serious side effects to this phone number.

Active Ingredient (Active ingredient)

Carbamide peroxide 6.5%

Other Information (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 (Inactive ingredients)

Glycerin, Lauroyl Sarcosine, Propylene Glycol


Advanced Ingredient Data


Raw Label Data

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