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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 30, 2023

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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 finalM01409/15/2022
    Labeler - Bionpharma Inc. (079637826)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(69452-377) , pack(69452-377)
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