Label: EAR DROPS- carbamide peroxide 6.5% liquid

  • NDC Code(s): 69452-377-75, 69452-377-95
  • Packager: Bionpharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2024

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  • Active ingredients

    Carbamide Peroxide 6.5% non USP*

    *pH differs from USP specifications

  • Purposes

    Earwax removal aid

  • Uses

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

  • Warnings

    Do not use

    • if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; consult a doctor
    • If you have an injury or perforation (hole) of the ear or after ear surgery, unless directed by a doctor
    • for more than 4 consecutive days. If excessive earwax remains after use of this product, consult a doctor.

    When using this product

    avoid contact with eyes
    Stop use and ask a doctor

    • you need to use for more than four days
    • excessive earwax remains after a four day treatment with this product

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    FOR USE IN THE EAR ONLY
    Remove any earing aids before use

    Adults and children over 12 yrs of age: tilt head to the side and place 10 drops into the ear.

    • Tip of applicator should not enter into the ear canal
    • Keep drops in ear for several minutes by keeping head tilted sideways 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 yrs of age: Consult a physician.

  • Other information

    • do not store above 77°F (25°C)
    • store bottle in outer carton
    • product foams on contact with ear was due to the release of oxygen. There may be an associated “crackling” sound.
    • keep cap on bottle when not in use
  • Inactive ingredients

    Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Purified Water.

  • Questions & comments?

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  • SPL UNCLASSIFIED SECTION

    a+health™

    ear drops
    carbamide
    peroxide 6.5%

    earwax
    removal aid

    SEALED FOR YOUR

    PROTECTION.

    DO NOT USE IF

    SHRINKBAND

    ON BOTTLE IS

    BROKEN OR MISSING

    AT TIME OF

    PURCHASE.

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

    DISTRIBUTED BY:
    Bionpharma Inc., Princeton, NJ 08540

    L0000592

    R0422

  • Carton labeling

    *compare to the active ingredient
    in Debrox® Ear Drops

    twin pack

    a+health™

    ear drops
    carbamide
    peroxide 6.5%

    earwax removal aid


    safe, gentle, non-irritating
    easily cleanses ear with
    microfoam action

    1 fl oz (30mL)
    two bottles 0.5 fl oz (15 mL) each

    Carton

  • INGREDIENTS AND APPEARANCE
    EAR DROPS 
    carbamide peroxide 6.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69452-377
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69452-377-952 in 1 CARTON09/15/2022
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:69452-377-751 in 1 CARTON09/15/2022
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01409/15/2022
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(69452-377) , pack(69452-377)
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