private label earwax removal- 0097

SPL v5

SPL

SPL Set ID a8c052d8-fb9c-09f2-e053-2a95a90a37af

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

Active Ingredient

Carbamide Peroxide 6.5%

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.

Cvs Label

Major Label

Leader Label

Rite Aid Label

Structured Label Content

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

Active Ingredient (55106-9)

Carbamide Peroxide 6.5%

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.

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.

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: 2026-02-15T12:02:31.896895 · Updated: 2026-03-14T23:02:08.105317