Label: EARWAX REMOVAL KIT RITE AID- carbamide peroxide 6.5% kit

  • NDC Code(s): 11822-1222-7, 11822-1224-1
  • Packager: Rite Aid
  • 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 June 23, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient                        Purpose

    Carbamide peroxide  6.5%          Earwax removal aid

  • PURPOSE

  • Uses

    For occasional use as an aid to soften, loosen and remove excessive earwax

  • Warnings


    Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery

    When using this product avoid contact with 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 the children
    If product is swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    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 of age: consult a doctor.

  • INACTIVE INGREDIENT

    Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

  • Rite Aid Earwax Kit

    Rite Aid Earwax Kit 2022Rite Aid Earwax Kit.jpg

  • INGREDIENTS AND APPEARANCE
    EARWAX REMOVAL KIT   RITE AID
    carbamide peroxide 6.5% kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1222
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1222-71 in 1 KIT; Type 0: Not a Combination Product10/04/2011
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 1 of 1
    EAR WAX RMVL   RITE AID
    carbamide peroxide 6.5% liquid
    Product Information
    Item Code (Source)NDC:11822-1224
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE6.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SODIUM STANNATE (UNII: NJ7C1V83KG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-1224-115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34410/04/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34410/04/2011
    Labeler - Rite Aid (014578892)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(11822-1224) , label(11822-1224, 11822-1222)