Drug Facts 25-119pq
4b601252-9b3b-4022-83b4-ca437254e4d9
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Carbamide peroxide 6.5% Earwax removal aid
Purpose
Carbamide peroxide 6.5% Earwax removal aid
Medication Information
Indications and Usage
For occasional use as an aid to soften, loosen and remove excessive earwax
Purpose
Carbamide peroxide 6.5% Earwax removal aid
Dosage and Administration
Directions
FOR USE IN THE 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 the 4-day treatment may 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
Description
Carbamide peroxide 6.5% Earwax removal aid
Section 50565-1
Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
Section 50567-7
When using this product • avoid contact with eyes.
If accidental contact with eyes occurs, flush eyes
with water and consult a doctor
Section 51727-6
Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water
Section 51945-4
Warnings
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) of the ear drum or after ear surgery, unless
directed by a doctor • for more than 4 consecutive
days; if excessive earwax remains after use of this
product, consult a doctor
Active Ingredient Purpose
Carbamide peroxide 6.5% Earwax removal aid
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)
Directions
FOR USE IN THE 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 the 4-day treatment may 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
Section 50565-1 (50565-1)
Keep out of reach of the children
If product is swallowed, get medical help or contact a Poison Control Center right away
Section 50567-7 (50567-7)
When using this product • avoid contact with eyes.
If accidental contact with eyes occurs, flush eyes
with water and consult a doctor
Section 51727-6 (51727-6)
Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water
Section 51945-4 (51945-4)
Warnings
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) of the ear drum or after ear surgery, unless
directed by a doctor • for more than 4 consecutive
days; if excessive earwax remains after use of this
product, consult a doctor
Active Ingredient Purpose (Active ingredient Purpose)
Carbamide peroxide 6.5% Earwax removal aid
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T11:56:28.629837 · Updated: 2026-03-14T22:54:57.914892