Label: REXALL EARWAX REMOVAL- carbamide peroxide kit

  • NDC Code(s): 55910-835-33, 55910-836-33
  • Packager: Dolgencorp LLC
  • 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 October 20, 2021

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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 eay 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 on bottle when not in use
    • Product foams on contact with earwax due to release of oxygen. There may be an associated 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?

    1-866-4-REXALL

  • Package Labeling:

    Kit 2Label3

  • INGREDIENTS AND APPEARANCE
    REXALL EARWAX REMOVAL 
    carbamide peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-835
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-835-331 in 1 BOX01/01/2019
    11 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 1 of 1
    REXALL EARWAX REMOVAL DROPS 
    carbamide peroxide solution/ drops
    Product Information
    Item Code (Source)NDC:55910-836
    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:55910-836-3315 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34401/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34401/01/2019
    Labeler - Dolgencorp LLC (068331990)
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