Private Label Earwax Removal- 0097

SPL v3

SPL

SPL Set ID e21e114c-99b6-861c-e053-2995a90aeac1

Route

AURICULAR (OTIC)

Published

Effective Date 2019-10-10

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (0.065 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2019-06-04

Description

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

Medication Information

Warnings and Precautions

For External Use Only.

Ask a doctor before use if you have:

Ear drainage or discharge

Ear pain, irritation, or rash in the ear

Recently had ear surgery

Dizziness

An injury or perforation (hole) of the eadrum

Indications and Usage

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

Dosage and Administration

Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

Description

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

Section 50565-1

Keep out of the reach of children. 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

Purified Water

Section 55105-1

Earwax removal aid.

Section 55106-9

Carbamide Peroxide 6.5%

Cvs Label

Major Label

Leader Label

Rite Aid Label

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)

Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

Warnings and Precautions (34071-1)

For External Use Only.

Ask a doctor before use if you have:

Ear drainage or discharge

Ear pain, irritation, or rash in the ear

Recently had ear surgery

Dizziness

An injury or perforation (hole) of the eadrum

Section 50565-1 (50565-1)

Keep out of the reach of children. 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

Purified Water

Section 55105-1 (55105-1)

Earwax removal aid.

Section 55106-9 (55106-9)

Carbamide Peroxide 6.5%

Cvs Label (CVS Label)

Major Label

Leader Label

Rite Aid Label

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STANNATE", "unii": "NJ7C1V83KG", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAUROYL SARCOSINATE", "unii": "632GS99618", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"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": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "0.065", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "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": "Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.", "34071-1": "For External Use Only. Ask a doctor before use if you have: Ear drainage or discharge Ear pain, irritation, or rash in the ear Recently had ear surgery Dizziness An injury or perforation (hole) of the eadrum", "50565-1": "Keep out of the reach of children. 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 Purified Water", "55105-1": "Earwax removal aid.", "55106-9": "Carbamide Peroxide 6.5%"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:35.329652 · Updated: 2026-03-14T23:02:13.859151