Label: EAR DROPS EARWAX REMOVAL AID- carbamide peroxide liquid

  • 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 28, 2013

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  • Active ingredient

    Carbamide Peroxide, 6.5%

  • Purpose

    Earwax removal aid

  • Uses

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

  • Warnings

  • ASK DOCTOR

    Ask a doctor before use if you have

    • ear drainage or discharge
    • ear pain
    • irritation or rash in the ear
    • dizziness
    • and injury or perforation (hole) of the ear drum
    • recently had ear surgery
  • Stop use and ask a doctor if

    • you need to use of r more than 4 days
    • excessive ear wax remains after use of this product
  • WHEN USING

    When using this product do not get into eyes

  • Keep out of reach of children

    In case of accidental overdose or allergic reaction, get medical help or contact a Poison Control Center immediately

  • Directions

    FOR USE IN THE EAR ONLY

    • Adults and children over 12 years of age:  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:  consult a doctor.
  • Other information

    • Avoid exposing bottle to excessive heat and direct sunlight.
    • Product foams on contact with earwax due to release of oxygen.  There may be an associated crackling.
    • Keep cap on bottle when not in use.
    • Lot no. and exp. date:  see label, bottom container or box.
  • Inactive ingredients

    Anhydrous Glycerin, Citric Acid, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

  • PRINCIPAL DISPLAY PANEL

    image of label

    image of carton

  • INGREDIENTS AND APPEARANCE
    EAR DROPS  EARWAX REMOVAL AID
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24385-955
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TARTARIC ACID (UNII: W4888I119H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24385-955-011 in 1 CARTON
    1NDC:24385-955-0215 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34401/01/2012
    Labeler - AmerisourceBergen Drug Corporation (Good Neighbor Pharmacy) (007914906)
    Registrant - Lee Pharmaceuticals (056425432)
    Establishment
    NameAddressID/FEIBusiness Operations
    AmerisourceBergen Drug Corporation007914906label(24385-955)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lee Pharmaceuticals056425432manufacture(24385-955)
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