Label: OTIX EAR WAX REMOVAL DROPS- carbamide peroxide solution/ drops

  • NDC Code(s): 15579-838-34
  • Packager: Bell Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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  • Drug Facts

  • 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

    For use in the ear only

    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 ear drum
    • 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 4 days
    • excessive earwax remains after use of this product

    Keep out of 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 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: consult a doctor
  • Other information

    • Avoid exposing bottle to excessive heat and direct sunlight
    • Store bottle in the outer carton
    • Keep cap in bottle when not in use
    • Product foams on contact with earwax due to release of oxygen. There may be an assoiciated crackling sound.
    • Do not use if tamper-evident safety seal is broken or missing
  • Inactive ingredients

    • anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water
  • Questions?

    1-800-328-5890

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    OTIX EAR WAX REMOVAL DROPS 
    carbamide peroxide solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15579-838
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15579-838-341 in 1 BOX10/01/2021
    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 DrugM01410/01/2021
    Labeler - Bell Pharmaceuticals, Inc. (140653770)
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