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 FINAL Active Since 2014-08-13

Medication Information

Indications and Usage

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

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

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 and ask doctor before use 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

Section 51945-4

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

Active Ingredient Purpose

Carbamide peroxide 6.5% Earwax removal aid

Structured Label Content

Indications and Usage (34067-9)

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 and ask doctor before use 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

Section 51945-4 (51945-4)

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

Active Ingredient Purpose (Active ingredient Purpose)

Carbamide peroxide 6.5% Earwax removal aid

Advanced Ingredient Data

[{"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "6.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Lauroyl Sarcosinate", "unii": "632GS99618", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sodium Stannate", "unii": "NJ7C1V83KG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "For occasional use as an aid to soften, loosen and remove excessive earwax", "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.", "50565-1": "Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product", "50567-7": "When using this product avoid contact with eyes", "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", "Active ingredient Purpose": "Carbamide peroxide 6.5% Earwax removal aid"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information