Label: EAR WAX REMOVAL DROPS- carbamide peroxide - 6.5% solution/ drops

  • NDC Code(s): 11527-143-51
  • Packager: Sheffield Pharmaceuticals LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2022

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

View All Sections
  • Active Ingredient

    Carbamide Peroxide 6.5%

  • Purpose 

    Earwax 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.

  • 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.
  • Inactive Ingredients 

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

  • Principal Display Panel -Bottle Label 

    Sheffield       

    Earwax Removal Aid Drops 

    Carbamide Peroxide 6.5%

    NET 0.5 FLOZ (15 ml )

    543480-Sheffield-Ear-Wax-Drops_BOX

    7004681B-Sheffield-Ear-Drops-LBL

  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVAL DROPS 
    carbamide peroxide - 6.5% solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-143
    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
    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:11527-143-511 in 1 CARTON02/02/2017
    115 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 DrugM01402/02/2017
    Labeler - Sheffield Pharmaceuticals LLC (151177797)
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!