5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b1
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredient Carbamide Peroxide 6.5%
Medication Information
Warnings and Precautions
Warnings
Indications and Usage
Uses
For occasional use as an aid to soften, loosen, and remove excessive earwax.
Dosage and Administration
D irections
FOR USE IN THE EAR ONLY Adults and children over 12 years of age:
tilt head sideways
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 four days if needed, or as directed by a doctor
any wax remaining after treatment may be removed by gently flusing the ear with warm water, using a soft rubber bulb ear syringe.
Children under 12 years: consult a doctor.
Description
Active Ingredient Carbamide Peroxide 6.5%
Section 50565-1
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Section 50566-9
Stop use and aks a doctor if
- you need to use for more than four days
- excessive earwax remains after use of this product
Section 50567-7
When using this product avoid contact wtih the eyes
Section 50569-3
Aska 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
Section 51727-6
Inactive ingredients
Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid
Section 51945-4
Section 53413-1
Questions or comments? 1-800-635-3696
Section 55105-1
Purpose
Earwax removal aid
Section 55106-9
Active Ingredient
Carbamide Peroxide 6.5%
Section 60561-8
Other informaiton
- store bottle in teh outer carton
- product foams on contact with earwax due to the release of oxygen. Theremay be an associated "crackling" sound
- keep cap on bottle when not in use
Structured Label Content
Indications and Usage (34067-9)
Uses
For occasional use as an aid to soften, loosen, and remove excessive earwax.
Dosage and Administration (34068-7)
D irections
FOR USE IN THE EAR ONLY Adults and children over 12 years of age:
tilt head sideways
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 four days if needed, or as directed by a doctor
any wax remaining after treatment may be removed by gently flusing the ear with warm water, using a soft rubber bulb ear syringe.
Children under 12 years: consult a doctor.
Warnings and Precautions (34071-1)
Warnings
Section 50565-1 (50565-1)
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Section 50566-9 (50566-9)
Stop use and aks a doctor if
- you need to use for more than four days
- excessive earwax remains after use of this product
Section 50567-7 (50567-7)
When using this product avoid contact wtih the eyes
Section 50569-3 (50569-3)
Aska 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
Section 51727-6 (51727-6)
Inactive ingredients
Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid
Section 51945-4 (51945-4)
Section 53413-1 (53413-1)
Questions or comments? 1-800-635-3696
Section 55105-1 (55105-1)
Purpose
Earwax removal aid
Section 55106-9 (55106-9)
Active Ingredient
Carbamide Peroxide 6.5%
Section 60561-8 (60561-8)
Other informaiton
- store bottle in teh outer carton
- product foams on contact with earwax due to the release of oxygen. Theremay be an associated "crackling" sound
- keep cap on bottle when not in use
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:56:26.711845 · Updated: 2026-03-14T22:54:55.117494