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
  • 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 January 23, 2020

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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
  • 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 finalpart34401/13/2020
    Labeler - BETTER LIVING BRANDS, LLC (009137209)
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