Ear Drops Major

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (6.5 g)

Inactive Ingredients

Sodium Stannate Glycerin Anhydrous Citric Acid Propylene Glycol Sodium Lauroyl Sarcosinate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2019-10-10 Until 2026-09-30

Medication Information

Warnings and Precautions

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

When using this product avoid contact with eyes

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

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

Keep out of reach of the children

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

Indications and Usage

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

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%

Section 50565-1

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

Section 51727-6

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

Section 51945-4

Section 55105-1

Earwax Removal Aid

Section 55106-9

Carbamide Peroxide 6.5%

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.

Warnings and Precautions (34071-1)

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

When using this product avoid contact with eyes

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

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

Keep out of reach of the children

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Earwax Removal Aid

Section 55106-9 (55106-9)

Carbamide Peroxide 6.5%

Advanced Ingredient Data

[{"name": "SODIUM STANNATE", "unii": "NJ7C1V83KG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "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": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "6.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

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.", "34071-1": "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 When using this product avoid contact with eyes Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product Stop use and ask a doctor if you need to use for more than four days • excessive earwax remains after use of this product Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away", "50565-1": "If swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water", "55105-1": "Earwax Removal Aid", "55106-9": "Carbamide Peroxide 6.5%"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information