Label: FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB- carbamide peroxide kit

  • NDC Code(s): 55319-835-01, 55319-836-01
  • Packager: Family Dollar Services Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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  • Drug Facts

  • Active ingredients

    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 flusing 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 on bottle when not in use
    • Produt foams on contact with earwax due to release of oxygen. There may be an associated crakling 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:

    Label2

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS EARWAX REMOVAL EARWAX AND BULB 
    carbamide peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-835
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-835-011 in 1 KIT11/01/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKAGE 15 mL
    Part 1 of 1
    FAMILY WELLNESS EARWAX REMOVAL 
    carbamide peroxide solution/ drops
    Product Information
    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:55319-836-011 in 1 BOX
    115 mL in 1 PACKAGE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01411/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01411/01/2019
    Labeler - Family Dollar Services Inc (024472631)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bell Pharmaceuticals, Inc.140653770manufacture(55319-835)
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