Label: DISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT- carbamide peroxide solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

If you are a consumer or patient please visit this version.

  • Drug facts


  • Active ingredient

    Carbamide peroxide 6.5%

    Purpose

    Earwax removal aid

  • Uses

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

  • Warnings

    For use in the ear only

    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 ear drum
    • 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 4 days
    • Excessive earwax remains after use of this product

    Keep out of reach of children

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

  • Directions

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

    Children under 12 years: consult a doctor

    • 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
  • 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

  • SPL UNCLASSIFIED SECTION

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

      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 Satisfaction Guaranteed

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


  • 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)

  • Product Labels

    FOOD FAIR 01

  • INGREDIENTS AND APPEARANCE
    DISCOUNT DRUG MART FOOD FAIR EARWAX REMOVAL KIT 
    carbamide peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53943-835
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53943-835-331 in 1 CARTON11/27/2014
    115 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01411/27/2014
    Labeler - Discount Drug Mart (047741335)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell Pharmaceuticals, Inc.140653770manufacture(53943-835)