488 - Earwax Removal Kit - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (65 mg)

Inactive Ingredients

Citric Acid Glycerin Propylene Glycol Sodium Citrate Sodium Lauryl Sulfate Tartaric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-28

Medication Information

Purpose

Earwax removal aid

Description

Carbamide peroxide 6.5%

Use(s)

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

Directions

FOR USE IN 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.

Children under 12 years of age: consult a doctor

Do Not Use

if you have ear drainage or discharge, ear pain, irritation or rash in the ear or are dizzy; consult a doctor
if you have an injury or perforation (hole) in the ear drum or after ear surgery, unless directed by a doctor
for more than 4 days; if excessive earwax remains after use of this product, consult a doctor

Other Information

• do not store above 86ºF (30ºC)

• protect from heat and direct sunlight

• DO NOT USE IF SHRINKBAND ON BOTTLE IS BROKEN OR MISSING

• Product foams on contact with earwax due to the release of oxygen. There may be an associated “crackling” sound.

• Keep cap on bottle when not in use

• Retain carton for full product information.

Questions/comments

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s)

Carbamide peroxide 6.5%

Inactive Ingredients

citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid

Principal Display Panel

Earwax label

Ear Wax Carton

When Using This Product

• avoid contact with eyes. If accidental contact with eyes occurs, flush

eyes with water and consult a doctor

Keep Out of Reach of Children

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

Structured Label Content

Use(s)

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

Purpose

Earwax removal aid

Directions

FOR USE IN 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.

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)

if you have ear drainage or discharge, ear pain, irritation or rash in the ear or are dizzy; consult a doctor
if you have an injury or perforation (hole) in the ear drum or after ear surgery, unless directed by a doctor
for more than 4 days; if excessive earwax remains after use of this product, consult a doctor

Other Information (Other information)

• do not store above 86ºF (30ºC)

• protect from heat and direct sunlight

• DO NOT USE IF SHRINKBAND ON BOTTLE IS BROKEN OR MISSING

• Product foams on contact with earwax due to the release of oxygen. There may be an associated “crackling” sound.

• Keep cap on bottle when not in use

• Retain carton for full product information.

Questions/comments (Questions/Comments)

Call 1-888-952-0050

(Monday-Friday 9 AM – 5 PM EST)

Active Ingredient(s) (Active ingredient(s))

Carbamide peroxide 6.5%

Inactive Ingredients (Inactive ingredients)

citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid

Principal Display Panel

Earwax label

Ear Wax Carton

When Using This Product (When using this product)

• avoid contact with eyes. If accidental contact with eyes occurs, flush

eyes with water and consult a doctor

Keep Out of Reach of Children (Keep out of reach of children)

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

Advanced Ingredient Data

[{"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "65", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID", "unii": "2968PHW8QP", "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": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TARTARIC ACID", "unii": "W4888I119H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use(s)": "For occasional use as an aid to soften, loosen and remove excessive earwax.", "Purpose": "Earwax removal aid", "Directions": "FOR USE IN 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. Children under 12 years of age: consult a doctor", "Do not use": "if you have ear drainage or discharge, ear pain, irritation or rash in the ear or are dizzy; consult a doctor if you have an injury or perforation (hole) in the ear drum or after ear surgery, unless directed by a doctor for more than 4 days; if excessive earwax remains after use of this product, consult a doctor", "Other information": "• do not store above 86ºF (30ºC) • protect from heat and direct sunlight • DO NOT USE IF SHRINKBAND ON BOTTLE IS BROKEN OR MISSING • Product foams on contact with earwax due to the release of oxygen. There may be an associated “crackling” sound. • Keep cap on bottle when not in use • Retain carton for full product information.", "Questions/Comments": "Call 1-888-952-0050 (Monday-Friday 9 AM – 5 PM EST)", "Active ingredient(s)": "Carbamide peroxide 6.5%", "Inactive ingredients": "citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid", "Principal Display Panel": "Earwax label Ear Wax Carton", "When using this product": "• avoid contact with eyes. If accidental contact with eyes occurs, flush eyes with water and consult a doctor", "Keep out of reach of children": "If product is swallowed, get medical help or contact a Poison Control Center right away."}

488 - Earwax Removal Kit

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information