Debrox 63029-321-01
8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Debrox Earwax Removal Aid Drug Facts
Purpose
Earwax removal aid
How Supplied
Product: 50090-4201 NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON
Medication Information
Purpose
Earwax removal aid
How Supplied
Product: 50090-4201
NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON
Description
Debrox Earwax Removal Aid Drug Facts
Uses
For occasional use as an aid to soften, loosen, and remove excessive earwax
Section 42229-5
Debrox Earwax Removal Aid
Drug Facts
Directions
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 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 the ear with warm water, using a soft rubber bulb ear syringe
children under 12 years: consult a doctor
Questions?
1-866-255-5202 Debrox.com
Active Ingredient
Carbamide peroxide 6.5% non USP
Other Information
- do not store above 25C (77F)
- store bottle in the outer carton, in an upright position
- product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.
- keep tip on bottle when not in use
Carbamide Peroxide
Inactive Ingredients
citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, 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 earwax 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 Poison Control Center (1-800-222-1222) right away.
Structured Label Content
Uses
For occasional use as an aid to soften, loosen, and remove excessive earwax
Section 42229-5 (42229-5)
Debrox Earwax Removal Aid
Drug Facts
Purpose
Earwax removal aid
Directions
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 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 the ear with warm water, using a soft rubber bulb ear syringe
children under 12 years: consult a doctor
Questions?
1-866-255-5202 Debrox.com
How Supplied (HOW SUPPLIED)
Product: 50090-4201
NDC: 50090-4201-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON
Active Ingredient (Active ingredient)
Carbamide peroxide 6.5% non USP
Other Information (Other information)
- do not store above 25C (77F)
- store bottle in the outer carton, in an upright position
- product foams on contact with earwax due to release of oxygen. There may be an associated “crackling” sound.
- keep tip on bottle when not in use
Carbamide Peroxide
Inactive Ingredients
citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, 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 earwax 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 Poison Control Center (1-800-222-1222) right away.
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:26.844108 · Updated: 2026-03-14T23:13:03.799451