Label: WALGREENS EAR WAX REMOVER- carbamide peroxide 6.5% liquid

  • NDC Code(s): 0363-2068-15, 0363-2068-25
  • Packager: Walgreens Company
  • 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 4, 2022

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  • Active ingredient 

    Carbamide Peroxide 6.5%

  • Purpose 

    Ear Wax 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

    • eardrainage, discharge, ear pain,irritation
    • rash in the ear,or are dizzy
    • injury or perforation (hole) of the ear drum
    • Recently had ear surgery
  • Stop Use and ask a Doctor if

    • you need to use for more than 4 days
    • execessive ear wax remain after use of this product
  • When using this product

    do not use for more than four days
    avoid contact with the eyes. If accidental contact with the eyes occurs, flush eyes with water and consult a doctor
    if excessive earwax remains after the use of this product, consult a doctor

  • Keep out of the 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 earwax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.
    • When the ear canal is irrigated, the tip of the ear syringe should not obstruct the flow of water leaving the ear canal.

    Children under 12 years: consult a doctor.

  • Inactive Ingredients 

    Citric Acid, Glycerin, Propylene Glycol, Sodium Citrate, Sodium Lauryl Sulfate, Tartaric Acid

  • Other information 

    Protect from heat and direct sunlight
    product foams on contact with ear wax due ot releae of oxygen, there may be associated cracking
    Keep cap on bottle when not in use.
    Lot No. and EXP date: see label, bottom container or box.

  • Principal Display Panel Bottle Label 0.5 FL OZ

    Walgreens Ear Wax Remover  NDC 0363-2068-15

    Ear Wax Removal drops

    Carbamide Peroxide 6.5%

    0.5 FL OZ (15ml)

    Principal Display Panel Bottle Label 0.5 FL OZ

  • Principal Display Panel Carton Label 0.5 FL OZ

    Walgreens Ear Wax Remover NDC 0363-2068-15

    Ear Wax Removal drops

    Carbamide Peroxide 6.5%

    0.5 FL OZ (15ml)

    Principal Display Panel Carton Label 0.5 FL OZ

  • Principal Display Panel Kit Label 0.5 FL OZ

    Walgreens Ear Wax Remover Kit  NDC 0363-2068-25

    Ear Wax Removal drops

    Carbamide Peroxide 6.5%

    0.5 FL OZ (15ml)

    Principal Display Panel Kit Label 0.5 FL OZ

  • INGREDIENTS AND APPEARANCE
    WALGREENS EAR WAX REMOVER 
    carbamide peroxide 6.5% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2068
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.065 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TARTARIC ACID (UNII: W4888I119H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2068-151 in 1 CARTON04/28/2014
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0363-2068-251 in 1 KIT04/28/2014
    215 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 finalpart34404/28/2014
    Labeler - Walgreens Company (008965063)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(0363-2068)
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