Label: SUAVEAR solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 9, 2016

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  • SuavEar

    SuavEar active ingredientCarbamide Peroxide 6.5%

  • DOSAGE & ADMINISTRATION

    For use in the ear only.

    Tilt head sideways. Place 5 to 10 drops in the ear, making sure that the tip of the applicator does not enter the ear canal. Keep drops in the ear for several minutes, either by using the included ear plugs 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 up to four days, or as directed by the doctor.

  • 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) in the eardrum
    • Recently had ear surgery

    Whe using this product avoid contact with the eyes.

    Stop use and ask a doctor if

    • You need to use it for more than 3 days in a row.
  • List of inactive ingredients

    Glycerin, Oxyquinoline

  • Ear canal cleaning

    For occasional aid to soften, loosen and remove excessive earwax

  • Purpose

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

  • Keep out of reach of children.

    Keep out of reach of children.

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    SUAVEAR 
    suavear solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13709-233
    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:13709-233-0115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product03/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/09/2016
    Labeler - NeilMed Pharmaceuticals Inc. (783557783)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeilMed Pharmaceuticals, Inc.799295915manufacture(13709-233)
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