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DEBROX

Medtech Products Inc.

Debrox Earwax Removal Aid




FULL PRESCRIBING INFORMATION

Drug Facts

Carbamide peroxide 6.5% non USP*

*pH differs from USP specifications

Earwax removal aid

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

  • 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

avoid contact with the eyes

  • you need to use for more than four days
  • excessive earwax remains after use of this product

If swallowed, get medical help or contact a Poison Control Center right away.

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

  • do not store above 77F (25C)
  • 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

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

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

Debrox® DROPS
Carbamide Peroxide 6.5% Non USP*
Earwax Removal Aid
Kit includes soft rubber bulb ear syringe and drops
½ FL OZ (15mL)

DEBROX

DEBROX

Carbamide Peroxide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63029-322
Route of Administration AURICULAR (OTIC) DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE 0.065 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
propylene glycol
SODIUM LAUROYL SARCOSINATE
SODIUM STANNATE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 7 in 1 BOTTLE, DROPPER
2 15 in 1 BOTTLE, DROPPER
3 NDC:63029-322-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part344 2012-06-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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