Earwax Removal Drops

SPL v2

SPL

SPL Set ID bd844af4-fbf0-459b-823d-b2a675f90c19

Route

TOPICAL

Published

Effective Date 2017-11-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (6.5 g)

Inactive Ingredients

Aloe Vera Leaf Chamomile Glycerin Oxyquinoline Sulfate Mineral Oil Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-11-12

Description

Carbamide Peroxide 6.5%

Purpose

Earwax removal aid

Medication Information

Purpose

Earwax removal aid

Description

Carbamide Peroxide 6.5%

Uses

for occasional use as an aid to soften, loosen and remove excessive ear wax

Section 51945-4

Directions

FOR USE IN THE EAR ONLY

adults and children over 12 years of age:

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

children under 12 years: consult a doctor

Active Ingredient

Carbamide Peroxide 6.5%

Other Information

store bottle in the outer carton
product foams on contact with ear wax due to release of oxygen. There may be an associated "cracklling" sound.
keep cap on bottle when not in use

Inactive Ingredients

Aloe Barbadensis Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Glycerin

Mineral Oil

Oxyquinoline Sulfate

Water

When Using This Product

avoid contact with the eyes

Stop Use and Ask A Doctor If

you need to use for more than four days
excessive ear wax remains after use of this product

Ask A Doctor Before Use If You Have

ear drainage or discharge
ear pain irritation or rash in the ear
dizziness
an injury or perforation (hole) of the eardrum
recently had ear surgery

Keep This and All Drugs Out of the Reach of Children.

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

Structured Label Content

Uses

for occasional use as an aid to soften, loosen and remove excessive ear wax

Section 51945-4 (51945-4)

Purpose

Earwax removal aid

Directions

FOR USE IN THE EAR ONLY

adults and children over 12 years of age:

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

children under 12 years: consult a doctor

Active Ingredient (Active ingredient)

Carbamide Peroxide 6.5%

Other Information (Other information)

store bottle in the outer carton
product foams on contact with ear wax due to release of oxygen. There may be an associated "cracklling" sound.
keep cap on bottle when not in use

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Extract

Chamomilla Recutita (Matricaria) Flower Extract

Glycerin

Mineral Oil

Oxyquinoline Sulfate

Water

When Using This Product (When using this product)

avoid contact with the eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you need to use for more than four days
excessive ear wax remains after use of this product

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

ear drainage or discharge
ear pain irritation or rash in the ear
dizziness
an injury or perforation (hole) of the eardrum
recently had ear surgery

Keep This and All Drugs Out of the Reach of Children. (Keep this and all drugs out of the reach of children.)

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

Advanced Ingredient Data

[{"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "6.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OXYQUINOLINE SULFATE", "unii": "61VUG75Y3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MINERAL OIL", "unii": "T5L8T28FGP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for occasional use as an aid to soften, loosen and remove excessive ear wax", "Purpose": "Earwax removal aid", "Directions": "FOR USE IN THE EAR ONLY adults and children over 12 years of age: 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 children under 12 years: consult a doctor", "Active ingredient": "Carbamide Peroxide 6.5%", "Other information": "store bottle in the outer carton product foams on contact with ear wax due to release of oxygen. There may be an associated "cracklling" sound. keep cap on bottle when not in use ", "Inactive ingredients": "Aloe Barbadensis Leaf Extract Chamomilla Recutita (Matricaria) Flower Extract Glycerin Mineral Oil Oxyquinoline Sulfate Water", "When using this product": "avoid contact with the eyes", "Stop use and ask a doctor if": "you need to use for more than four days excessive ear wax remains after use of this product", "Ask a doctor before use if you have": "ear drainage or discharge ear pain irritation or rash in the ear dizziness an injury or perforation (hole) of the eardrum recently had ear surgery", "Keep this and all drugs out of the reach of children.": "If swallowed, get medical help or contact a Posion Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:26.649653 · Updated: 2026-03-14T22:54:54.026912