Label: EARWAX REMOVAL DROPS- carbamide peroxide 6.5% liquid

  • NDC Code(s): 0395-9133-45, 0395-9133-90
  • Packager: Humco Holding Group, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • INACTIVE INGREDIENT

    Citric Acid

    Flavor

    Glycerin

    Propylene Glycol

    Sodium Lauroyl Sarcosinate

    Sodium Stannate

    Purified Water

  • PURPOSE

    Earwax removal aid.

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 yrs of age: tilt head to the side and place 5 to 10 drops into the ear canal.

  • KEEP OUT OF REACH OF CHILDREN

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

  • WARNINGS

    For External Use Only.

    Ask a doctor before use if you have:

    Ear drainage or discharge

    Ear pain, irritation, or rash in the ear

    Recently had ear surgery

    Dizziness

    An injury or perforation (hole) of the eadrum

  • ACTIVE INGREDIENT

    Carbamide Peroxide 6.5%

  • INDICATIONS & USAGE

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

  • CVS Label

    CVSWax.jpgcarton

  • Leader Label

    Leader2022LDREarwax45.jpgLDREwawax90.jpg

  • Rite Aid Label

    Rite Aid Earwax Kit 2022RAEarwax45.jpgRAEarwax90.jpg

  • Major Label

    MajorEarwax90.jpg

  • INGREDIENTS AND APPEARANCE
    EARWAX REMOVAL DROPS 
    carbamide peroxide 6.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9133
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9133-901 in 1 CARTON06/04/2019
    115 mL in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:0395-9133-451 in 1 CARTON06/04/2019
    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 DrugM01406/04/2019
    Labeler - Humco Holding Group, Inc (825672884)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(0395-9133) , analysis(0395-9133) , pack(0395-9133) , label(0395-9133)
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