Debrox 63029-321-01

Debrox 63029-321-01
SPL v13
SPL
SPL Set ID 8d6f1769-eb44-4bde-b3fa-3ff4658b7dd1
Route
AURICULAR (OTIC)
Published
Effective Date 2025-09-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrogen Peroxide (65 mg)
Inactive Ingredients
Citric Acid Glycerin Propylene Glycol Sodium Lauroyl Sarcosinate Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-08-01

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

All Sections (JSON)