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  5. Label Information: Debrox

FDA Label for Debrox

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. ASK A DOCTOR BEFORE USE IF YOU HAVE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS?
    13. DEBROX EARWAX REMOVAL AID 0.5 FL OZ (15 ML)

Debrox Product Label

The following document was submitted to the FDA by the labeler of this product Medtech Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



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 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.


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


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?



1-866-255-5202   Debrox.com


* Please review the disclaimer below.