Earwax Removal Aid

Drug Facts

Composition & Product

Active Ingredients

Hydrogen Peroxide (6.5 mg)

Inactive Ingredients

Glycerin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2008-08-31

Medication Information

Purpose

Earwax Removal Aid

Description

Carbamide Peroxide 6.5%

Use(s)

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

Storage

Store at controlled room temperature 15 to 30C (59 to 86F)
KEEP IN A DRY PLACE

Warning

For External Use Only

Directions

FOR USE IN THE EAR ONLY

Adults and children 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 my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age, consult a doctor.

Do Not Use

In the eye
for more than 4 days

Other Information

Do not use if imprinted seal on cap is broken or missing.

Active Ingredient(s)

Carbamide Peroxide 6.5%

Inactive Ingredients

anhydrous Glycerin

Questions Or Comments?

Call 1-800-328-2742

Principal Display Panel

Principle display panel:

Flents Earwax Removal Kit Box

Stop Use and Ask A Doctor If

Stop use and ask a doctor if excessive earwax remains after use

Keep Out of Reach of Children

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

Ask A Doctor Before Use If You Have

ear drainage or discharge
pain, irritation or rash in the ear
had ear surgery
an injury or perforation (hole) in the ear drum

Structured Label Content

Use(s)

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

Purpose

Earwax Removal Aid

Storage

Store at controlled room temperature 15 to 30C (59 to 86F)
KEEP IN A DRY PLACE

Warning

For External Use Only

Directions

FOR USE IN THE EAR ONLY

Adults and children 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 my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age, consult a doctor.

Do Not Use (Do not use)

In the eye
for more than 4 days

Other Information (Other information)

Do not use if imprinted seal on cap is broken or missing.

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

Carbamide Peroxide 6.5%

Inactive Ingredients

anhydrous Glycerin

Questions Or Comments? (Questions or Comments?)

Call 1-800-328-2742

Principal Display Panel

Principle display panel:

Flents Earwax Removal Kit Box

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

Stop use and ask a doctor if excessive earwax remains after use

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

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

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

ear drainage or discharge
pain, irritation or rash in the ear
had ear surgery
an injury or perforation (hole) in the ear drum

Advanced Ingredient Data

[{"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "ACTIB", "strengthNumerator": "6.5", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "120.0", "strengthDenominator": "100", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Use(s)": " For occasional use to soften, loosen and remove excessive earwax.", "Purpose": "Earwax Removal Aid", "Storage": "Store at controlled room temperature 15 to 30C (59 to 86F) KEEP IN A DRY PLACE", "Warning": " For External Use Only", "Directions": " FOR USE IN THE EAR ONLY Adults and children 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 my be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. Children under 12 years of age , consult a doctor.", "Do not use": " In the eye for more than 4 days", "Other information": " Do not use if imprinted seal on cap is broken or missing.", "Active ingredient(s)": " Carbamide Peroxide 6.5%", "Inactive Ingredients": " anhydrous Glycerin", "Questions or Comments?": "Call 1-800-328-2742", "Principal Display Panel": " Principle display panel: Flents Earwax Removal Kit Box", "Stop use and ask a doctor if": " Stop use and ask a doctor if excessive earwax remains after use", "Keep out of reach of children": "If swallowed, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "ear drainage or discharge pain, irritation or rash in the ear had ear surgery an injury or perforation (hole) in the ear drum"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information