Label: EAR WAX REMOVAL AID DROPS- carbamide peroxide liquid

  • NDC Code(s): 21130-793-15
  • Packager: BETTER LIVING BRANDS, LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 14, 2023

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  • SPL UNCLASSIFIED SECTION

    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 ear wax

  • 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 four days
    ▪
    excessive ear wax remains after use this product

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    FOR USE IN THE EAR ONLY.

    ▪
    Adults and children over 12 years of age:
    ▪
    tilt head sideways
    ▪
    place 5 to 10 drops into ear canal.
    ▪
    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 of age: consult a doctor.

  • Other information

    ▪
    store at room temperature
    ▪
    avoid exposing bottle to excessive heat and direct sunlight
    ▪
    store bottle in the outer carton
    ▪
    product foams on contact with earwax due to release of oxygen. There may be an associated “cracking” sound.
    ▪
    keep cap on bottle when not in use
  • Inactive ingredients

    adipic acid, anhydrous glycerin, polysorbate 80

  • Questions? 1-866-467-2748

  • PRINCIPAL DISPLAY PANEL

    *Compare to the active ingredient in Debrox® Drops

    NDC 21130-793-15

    Ear Wax Removal Aid Drops
    Carbamide Peroxide 6.5%

    Ear Wax Removal Aid

    •
    Safe & Gentle
    •
    Microfoam Cleansing Action
    •
    Easy to use Instructions

    NET WT 0.5 FL OZ (15 mL)

    TAMPER EVIDENT: DO NOT USE IF OUTER CARTON IS OPEN OR TORN

    DISTRIBUTED BY BETTER LIVING BRANDS LLC

    P.O. BOX 99, PLEASANTON, CA 94566-0009

    1-888-723-3929

    www.betterlivingbrandsLLC.com

    IMPORTANT: Keep this carton for future labeling.

    *This product is not manufactured or distributed by Medtech Products Inc. the distributor of Debrox® Drops.

    Ear Wax Removal Aid Drops
    Ear Wax Removal KIT 0.5 Fl oz. 15 mL
  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVAL AID DROPS 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-793
    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
    ADIPIC ACID (UNII: 76A0JE0FKJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-793-151 in 1 CARTON01/13/2020
    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 DrugM02201/13/2020
    Labeler - BETTER LIVING BRANDS, LLC (009137209)
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