Label: SUAVEAR EARWAX REMOVAL AID- earwax removal aid solution/ drops

  • NDC Code(s): 13709-312-01
  • Packager: NEILMED PHARMACEUTICALS INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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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 earwax

  • 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
  • When using this product

    Avoid contact with the eyes

  • Stop use and ask a doctor if

    • You need to use for more than 3 days in a row
  • Keep this and all drugs out of the reach of children

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

  • Directions

    FOR USE IN THE EAR ONLY

    Adults and children 12 years of age:

    • Tilt head sideways
    • Place 5 to 10 drops into the ear, making sure that the tip of the applicator does not enter the earcanal
    • Keep drops in the ear for sevaral minutes, either by using teh included earplugs or keeping the head tilted to the side
    • Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using the enclosed soft silicone bulb
    • Use twice daily for upto four days, or as directed by a doctor

    Children under 12 years: consult a doctor

  • Other Information

    • Store bottle in the outer carton
    • Product foams on contact with earwax due to release of oxygen. There may be associated "crackling" sound.
    • Keep cap on bottle when not in use

  • Inactive Ingredients

    Glycerin

    Oxyquinoline

  • Product label : SuavEar Earwax Removal Aid

    Suavear

  • INGREDIENTS AND APPEARANCE
    SUAVEAR EARWAX REMOVAL AID 
    earwax removal aid solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-312
    Route of AdministrationAURICULAR (OTIC)
    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)  
    OXYQUINOLINE (UNII: 5UTX5635HP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13709-312-011 in 1 KIT04/22/2021
    115 mL in 1 BOTTLE, DROPPER; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01404/22/2021
    Labeler - NEILMED PHARMACEUTICALS INC (799295915)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEILMED PHARMACEUTICALS INC799295915manufacture(13709-312)
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