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 March 16, 2022

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

  • DOSAGE & ADMINISTRATION

    FOR USE IN THE EAR ONLY

    Adults & Children over 12 yrs of age:

    Tilt head to the side and place 5-10 drops into ear.

    Dropper tip of removal drops 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.

    Safely scoop out wax with removal tool.

    Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the ear bulb syringe.

    Children under 12 yrs of age:

    Consult a doctor.

  • INDICATIONS & USAGE

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

  • PURPOSE

    Earwax Removal Aid

  • ACTIVE INGREDIENT

    Carbamide Peroxide 6.5%

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Extract

    Chamomilla Recutita (Matricaria) Flower Extract

    Glycerin

    Mineral Oil

    Oxyquinoline Sulfate

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1212) right away.

  • WHEN USING

    When using this product avoid contact with eyes.

  • STOP USE

    Stop use and ask a doctor if:

    you need to use more than four days

    excessive earwax remains after use of this product

  • OTHER SAFETY INFORMATION

    Other Information

    Do not use if neck wrap imprinted safety seal is broken or missing

    Do not store above 25 degrees C, 77 degrees F

    Store bottle in outer carton

    Keep cap on bottle when not in use

    Product foams on contacy with earwax due to release of oxygen

  • WARNINGS

    Warnings

    Ask a doctor before use 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

  • PRINCIPAL DISPLAY PANEL

    ERO Label.jpgERO IFC.jpg

  • INGREDIENTS AND APPEARANCE
    EARWAX REMOVAL DROPS 
    carbamide peroxide 6.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-600
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-600-051 in 1 CARTON07/03/2020
    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 finalpart34407/03/2020
    Labeler - Randob Labs, Ltd. (061995007)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(52412-600) , analysis(52412-600) , label(52412-600) , pack(52412-600)