Label: CVS HEALTH EARWAX REMOVAL KIT- carbamide peroxide kit

  • NDC Code(s): 51316-822-00, 51316-823-00
  • Packager: CVS Pharmacy, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 17, 2024

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

View All Sections
  • 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 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 (1-800-222-1222) 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
    • Store at 15-30ºC (59-86ºF)
    • 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?

    1-800-328-5890
    Weekdays 8:30-5:00 CST

  • Kit

    KitBox

  • Package Labeling:

    ComponentComponent2

  • INGREDIENTS AND APPEARANCE
    CVS HEALTH EARWAX REMOVAL KIT 
    carbamide peroxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-823
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-823-001 in 1 KIT08/01/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 15 mL
    Part 1 of 1
    CVS HEALTH EARWAX REMOVAL DROPS EARWAX REMOVAL AID 
    carbamide peroxide solution/ drops
    Product Information
    Item Code (Source)NDC:51316-822
    Route of AdministrationTOPICAL
    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:51316-822-001 in 1 BOX
    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 DrugM01408/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01408/01/2024
    Labeler - CVS Pharmacy, Inc. (062312574)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!