Leader Earwax Removal Kit

SPL v10

SPL

SPL Set ID 883d65e1-78ab-be9d-e053-2a95a90aa591

Route

AURICULAR (OTIC)

Published

Effective Date 2019-05-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (6.5 g)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2019-05-06 Until 2026-04-30

Description

Carbamide Peroxide 6.5% non USP* *pH differs from USP specifications

Medication Information

Warnings and Precautions

Ask a doctor before use if you have:

ear drainage or discharge

ear pain, irritation, or rash in ear

recently had ear surgery

dizziness

an injury or perforation of the eardrum

Indications and Usage

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

Dosage and Administration

tilt head sideways
palce 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 four days if needed, or as directed by a doctor
any wax remaining after treatment may be removed by gently flushing ear with warm water, using a soft rubber bulb ear syringe

Description

Carbamide Peroxide 6.5% non USP* *pH differs from USP specifications

Section 50565-1

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

Section 51727-6

Citric acid

Flavor

Glyrcerin

Propylene glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified water

Section 51945-4

Section 55105-1

Earwax removal aid

Section 55106-9

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

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)

tilt head sideways
palce 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 four days if needed, or as directed by a doctor
any wax remaining after treatment may be removed by gently flushing ear with warm water, using a soft rubber bulb ear syringe

Warnings and Precautions (34071-1)

Ask a doctor before use if you have:

ear drainage or discharge

ear pain, irritation, or rash in ear

recently had ear surgery

dizziness

an injury or perforation of the eardrum

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Citric acid

Flavor

Glyrcerin

Propylene glycol

Sodium Lauroyl Sarcosinate

Sodium Stannate

Purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Earwax removal aid

Section 55106-9 (55106-9)

Carbamide Peroxide 6.5% non USP*

*pH differs from USP specifications

Advanced Ingredient Data

[{"name": "SODIUM LAUROYL SARCOSINATE", "unii": "632GS99618", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STANNATE", "unii": "NJ7C1V83KG", "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": "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": "tilt head sideways palce 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 four days if needed, or as directed by a doctor any wax remaining after treatment may be removed by gently flushing ear with warm water, using a soft rubber bulb ear syringe", "34071-1": "Ask a doctor before use if you have: ear drainage or discharge ear pain, irritation, or rash in ear recently had ear surgery dizziness an injury or perforation of the eardrum", "50565-1": "If swallowed, get medical help or contact a Posion Control Center right away.", "51727-6": "Citric acid Flavor Glyrcerin Propylene glycol Sodium Lauroyl Sarcosinate Sodium Stannate Purified water", "55105-1": "Earwax removal aid", "55106-9": "Carbamide Peroxide 6.5% non USP* *pH differs from USP specifications"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:38.726639 · Updated: 2026-03-14T23:09:31.593516