Label: EARWAX REMOVAL KIT- carbamide peroxide liquid

  • Category: HUMAN OTC DRUG LABEL

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 13, 2022

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  • PURPOSE

    Earwax removal aid

  • Drug Facts

    Active ingredient

    Active ingredientPurpose
    Carbamide peroxide 6.5%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 per1oration (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 earwax remains after use of this product.

    Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center immediately.

  • 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 ■ 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 four 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

    ■ 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

    Glycerin, Polysorbate 20, Propylene glycol, Sodium citrate, Tartaric acid

  • Questions or comments?

    (496) 845-2722

  • Principal Display Panel

    Lucid Wellness™

    EARWAX

    REMOVAL KIT™

    Effectively removes

    excessive buildup

    with fast foaming acion

    — CARBAMIDE PEROXIDE 6.5%

    Kit includes:

    Soft BulbSyringe and Drops

    EASY | EFFECTIVE | SAFE

    NET WT. 0.5 FL OZ (14.8 mL)

    Carton

  • Principal Display Panel

    LABEL

  • INGREDIENTS AND APPEARANCE
    EARWAX REMOVAL KIT 
    carbamide peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76928-1000
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TARTARIC ACID (UNII: W4888I119H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76928-1000-11 in 1 CARTON05/18/2020
    114.8 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/18/2020
    Labeler - Lucid Wellness (117497048)
    Registrant - Wisconsin Pharmacal Company (800873986)
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