Label: DG HEALTH EARWAX REMOVAL KIT- carbamide peroxide 6.5% solution/ drops

  • NDC Code(s): 75712-301-14
  • Packager: DOLLAR GENERAL CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

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  • Active ingredient

    Carbamide peroxide, 6.5%

  • Purpose

    Ear wax Remover

  • 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 

    DG Health

    Ear Wax Removal Kit

    Carbamide Peroxide 6.5%

    0.5 FLOZ (15mL)

    707880 label- bottle

  • Principal Display Panel- Carton label 0.5 FLOZ 

    DG Health

    Ear Wax Removal Kit

    Carbamide Peroxide 6.5%

    0.5 FLOZ (15mL)


    507880 carton- label

    507880 carton- label
  • INGREDIENTS AND APPEARANCE
    DG HEALTH EARWAX REMOVAL KIT 
    carbamide peroxide 6.5% solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-301
    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:75712-301-141 in 1 CARTON11/01/2023
    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 DrugM01411/01/2023
    Labeler - DOLLAR GENERAL CORPORATION (006946172)
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