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

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 June 23, 2022

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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 finalpart34406/04/2019
    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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