Label: EARWAX REMOVAL DROPS- 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 December 19, 2020

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    Adults & Children over 12 yrs of age:

    tilt head to the side and place 10 drops into the ear canal.

    Tip of applicator should not enter into the ear canal

    Keep drops in ear for several minutes by keeping head tilted sideways 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 yrs of age:

    Consult a physician.

  • INDICATIONS & USAGE

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

  • PURPOSE

    Earwax Removal Aid

  • WARNINGS

    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 surgery

    dizziness

    an injury or perforation (hole) of the eardrum

  • ACTIVE INGREDIENT

    Carbamide Peroxide 6.5%

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Extract

    Chamomilla Recutita (Matricaria) Flower Extract

    Glycerin

    Mineral Oil

    Oxyquinoline Sulfate

    Purified Water

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    EARWAX REMOVAL DROPS 
    carbamide peroxide 6.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-096
    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
    CHAMOMILE (UNII: FGL3685T2X)  
    OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-096-451 in 1 CARTON06/05/2019
    115 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 finalpart34406/05/2019
    Labeler - CVS Pharmacy (062312574)
    Registrant - Humco Holding Group, Inc (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc825672884manufacture(69842-096) , analysis(69842-096) , label(69842-096) , pack(69842-096)