FDA Label for Discount Drug Mart Food Fair Earwax Removal Kit

View Indications, Usage & Precautions

Discount Drug Mart Food Fair Earwax Removal Kit Product Label

The following document was submitted to the FDA by the labeler of this product Discount Drug Mart. 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.

Drug Facts





Active Ingredient



Carbamide peroxide 6.5%


Uses



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


Warnings



For use in the ear only


Directions



FOR USE IN THE EAR ONLY
Adults and children over 12 years of age:

  • Tilt head sideways and 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 titled or placing cotton in the ear
  • Use twice daily for up to 4 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



  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen.  There many be an associated cracking sound
  • Do not use if tamper-evident safety seal is broken or missing

Inactive Ingredients



anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water


Questions?



1-800-328-5890


Other



*This product is not manufactured or distributed by Prestige Brands Inc. owner of the registered trademark Debrox.

Satisfaction Guaranteed  If Dissatisfied, Return Unused Portion And Package To Store Where Purchased. If Unable To Return To Store, Send Reason For Dissatisfaction. Name, Address And Empty Package To: Discount Drug Mart, 211 Commerce Drive, Median Ohio 44256


Distributed By: Drug Mart-Food Fair 211 Commerce Dr., Median, Ohio 44256 Made in the USA


Package Label.Principal Display Panel



Discount Drug Mart Food Fair Earwax Removal Kit  Earwax Removal Aid  Carbamide Peroxide 6.5%  Safe, Gentle, Non-Irritating  Washer Bulb Included 0.5 FL OZ (15 mL)


* Please review the disclaimer below.