DEBROX- carbamide peroxide liquid

DEBROX by

Drug Labeling and Warnings

DEBROX by is a Otc medication manufactured, distributed, or labeled by Denison Pharmaceuticals, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Carbamide peroxide 6.5% non USP*

*pH differs from USP specifications

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

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

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

Keep out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Warnings

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 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 flushing the ear with warm water, using a soft rubber bulb ear syringe

children under 12 years: consult a doctor

Other information

• do not store above 25C (77F)
  
• store bottle in the outer carton
  
• 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

Inactive ingredients

citric acid, flavor, glycerin, propylene glycol, sodium lauroyl sarcosinate, water

Questions or comments?

call toll-free 1-866-255-5202 (English/Spanish) weekdays

PRINCIPAL DISPLAY PANEL

Debrox® DROPS
Carbamide Peroxide 6.5% Non USP*
Earwax Removal Aid
½ FL OZ (15mL)

INGREDIENTS AND APPEARANCE

DEBROX 
carbamide peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0295-1231
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	CARBAMIDE PEROXIDE	0.065 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0295-1231-02	1 in 1 CARTON	01/01/2017
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part344	01/01/2017

Labeler - Denison Pharmaceuticals, LLC. (001207208)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmaceuticals, LLC.		001207208	MANUFACTURE(0295-1231)