Rite Aid Earwax Kit

Rite Aid Earwax Kit
SPL v5
SPL
SPL Set ID da78ac58-6c1c-4fa9-baac-e9dec0241385
Route
AURICULAR (OTIC)
Published
Effective Date 2018-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (6.5 g)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Propylene Glycol Sodium Lauroyl Sarcosinate Sodium Stannate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-10-04

Description

Carbamide peroxide  6.5%          Earwax removal aid

Purpose

Carbamide peroxide  6.5%          Earwax removal aid


Medication Information

Purpose

Carbamide peroxide  6.5%          Earwax removal aid

Dosage and Administration

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.

Description

Carbamide peroxide  6.5%          Earwax removal aid

Uses

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

Section 50565-1

Keep out of reach of the children

If product is swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if ​you need to use for more than four days • excessive earwax remains after use of this product

Section 50567-7

When using this product avoid contact with eyes

Section 51727-6

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

Warnings



Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

Rite Aid Earwax Kit

Active Ingredient                        Purpose

Carbamide peroxide  6.5%          Earwax removal aid


Structured Label Content

Uses

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

Dosage and Administration (34068-7)

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.

Section 50565-1 (50565-1)

Keep out of reach of the children

If product is swallowed, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if ​you need to use for more than four days • excessive earwax remains after use of this product

Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 51727-6 (51727-6)

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

Warnings



Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

Rite Aid Earwax Kit

Active Ingredient                        Purpose (Active ingredient                        Purpose)

Carbamide peroxide  6.5%          Earwax removal aid


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)