Label: LEADER EARWAX REMOVAL KIT- carbamide peroxide 6.50% kit liquid

  • NDC Code(s): 70000-0490-1, 70000-0490-2
  • Packager: Cardinal Health, 110 dba Leader
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 22, 2023

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  • ACTIVE INGREDIENT

    Carbamide Peroxide 6.5% non USP*

    *pH differs from USP specifications

  • PURPOSE

    Earwax removal aid

  • INDICATIONS & USAGE

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

  • WARNINGS

    Ask a doctor before use if you have:

    ear drainage or discharge

    ear pain, irritation, or rash in ear

    recently had ear surgery

    dizziness

    an injury or perforation of the eardrum

  • INACTIVE INGREDIENT

    Citric acid

    Flavor

    Glyrcerin

    Propylene glycol

    Sodium Lauroyl Sarcosinate

    Sodium Stannate

    Purified water

  • DOSAGE & ADMINISTRATION

    • ​tilt head sideways
    • palce 5 to 10 drops into ear
    • tip of applicator should not enter ear canal
    • keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
    • use twice daily for up to four days if needed, or as directed by a doctor
    • any wax remaining after treatment may be removed by gently flushing ear with warm water, using a soft rubber bulb ear syringe
  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    Leader Earwax Carton 12-30-22Leader Earwax Label 12-30-22Leader2022LDRWax.jpglabel

  • INGREDIENTS AND APPEARANCE
    LEADER EARWAX REMOVAL KIT 
    carbamide peroxide 6.50% kit liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0490
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0490-215 mL in 1 CONTAINER; Type 0: Not a Combination Product05/06/2019
    2NDC:70000-0490-11 in 1 CARTON05/06/2019
    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 DrugM01405/06/2019
    Labeler - Cardinal Health, 110 dba Leader (063997360)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114pack(70000-0490) , label(70000-0490) , manufacture(70000-0490) , analysis(70000-0490)
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