Label: AURO EAR WAX REMOVER- carbamide peroxide liquid

  • 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 31, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Carbamide peroxide 6.5% in anhydrous glycerin

  • Purpose

    Earwax removal aid

  • Uses

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

  • Warnings

    Flammable, keep away from fire or flame.

    FOR EAR USE ONLY

    Do not use for more than 4 days

    Ask a doctor before use if you have

    • ear drainage or discharge
    • ear pain, irritation or rash in the ear or are dizzy
    • an injury or perforation (hole) of the eardrum
    • had ear surgery

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if excessive earwax remains after use

    Keep out of reach of children.

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

  • Directions

    adults and children 12 years of age and older

    • tilt head sideways and place 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 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 years of age consult a doctor
  • Other information

    • recap tube after each use
    • store at room temperature
    • keep carton for full drug facts
  • Inactive ingredients

    disodium EDTA, disodium laureth sulfosuccinate, isopropyl alcohol, methylparaben, methyl salicylate, propylene glycol, purified water

  • Questions?

    call 1-800-344-7239

  • SPL UNCLASSIFIED SECTION

    Distributed:
    INSIGHT Pharmaceuticals Corp.
    Langhorne, PA 19047-1749

  • PRINCIPAL DISPLAY PANEL - 22mL Tube Carton

    DOCTOR
    RECOMMENDED
    INGREDIENT

    AURO®
    EAR DROPS

    CARBAMIDE PEROXIDE 6.5%
    in anhydrous glycerin

    EARWAX
    REMOVAL AID

    SAFE ■ FAST ■ EFFECTIVE
    when used as directed

    SAFETY SEALED
    TUBE TIP

    0.75 fl oz. (22mL)

    PRINCIPAL DISPLAY PANEL - 22mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    AURO EAR WAX REMOVER 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-232
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Carbamide peroxide (UNII: 31PZ2VAU81) (Carbamide peroxide - UNII:31PZ2VAU81) Carbamide peroxide1.44 mL  in 22 mL
    Inactive Ingredients
    Ingredient NameStrength
    Edetate Disodium (UNII: 7FLD91C86K)  
    Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63736-232-241 in 1 BOX
    122 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34407/01/2010
    Labeler - Insight Pharmaceuticals LLC (176792315)
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