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

  • NDC Code(s): 49035-862-01, 49035-862-02
  • Packager: WALMART STORES INC
  • 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 November 7, 2018

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  • 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 0.5 FL OZ

    Equate NDC 49035-862-02

    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

    Equate       NDC 49035-862-02

    Ear wax Remover Drops 

    Carbamide Peroxide 6.5%

    Ear wax removal aid 

    0.5 FL OZ ( 15ml)

    Principal Display Panel - Carton label 0.5 FLOZ

    Principal Display Panel - Carton label 0.5 FLOZ

  • Principal Display Panel - Carton label KIT 0.5 FL OZ

    Equate NDC 49035-862-02

    Ear wax Remover Kit

    Carbamide Peroxide 6.5%

    Ear wax removal aid

    0.5 FL OZ ( 15ml)

    image description

  • INGREDIENTS AND APPEARANCE
    EAR WAX REMOVAL DROPS  EQUATE
    carbamide peroxide - 6.5% solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-862
    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:49035-862-021 in 1 CARTON03/01/2019
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:49035-862-011 in 1 KIT03/01/2019
    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 finalpart34403/01/2019
    Labeler - WALMART STORES INC (051957769)
    Registrant - Sheffield Pharmaceuticals LLC (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sheffield Pharmaceuticals LLC151177797manufacture(49035-862)
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