Label: ERO EAR WAX REMOVAL KIT- carbamide peroxide 6.5% 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 May 18, 2023

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  • ACTIVE INGREDIENT

    Carbamide Peroxide 6.5%

  • 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

    • if you have ear drainage or discharge, ear pain, irritation or rash in the ear, dizziness
    • an injury or perforation (hole) of the eardrum, recently had ear surgery

    When using this product avoid contact with the eyes

    Stop use and ask a doctor if you need to use for more than four days, excessive earwax remains after use of this product.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    FOR IN EAR USE 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 of age: consult a doctor.

  • INACTIVE INGREDIENT

    Aloe Barbadensis Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    ERO EAR WAX REMOVAL KIT 
    carbamide peroxide 6.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-175
    Route of AdministrationTOPICAL
    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
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TARTARIC ACID (UNII: W4888I119H)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-175-011 in 1 CARTON04/16/2021
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01404/16/2021
    Labeler - Randob Labs (061995007)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(52412-175)
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