Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 53329-980-04, 53329-980-08
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 29, 2024

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  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

  • Purpose

    First aid antiseptic

    Oral debriding agent

  • Uses

    • first aid to help prevent the risk of infection in minor cuts,scrapes and burns
    • aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
  • Warnings

    For external use only

    Do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week

    Ask a doctor before use if you have

    deep or puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness persists or worsens
    • swelling, rash, or fever develops

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    First aid antiseptic:

    • clean the affected area
    • apply a small amount of product on the affected area 1 to 3 times a day
    • may be covered with a sterile bandage
    • if bandaged, let dry first

    Oral debriding agent: adults, children over 2 years of age:

    • mix with an equal amount of water
    • swish around in the mouth over the affected area for at least 1 minute, then spit out
    • use up to 4 times daily after meals and at bedtime
    • children under 12 years of age should be supervised in the use
    • children under 2 years of age: consult a dentist, doctor

  • Other information

    Keep tightly closed. Protect from freezing, avoid excessive heat. Do not shake bottle. Hold away from face when opening.

  • Inactive ingredient

    purified water

  • Manufacturing Information

    Manufactured for:
    Medline Industries, LP
    Three Lakes Drive, Northfield, IL 60093 USA
    Made in USA with domestic and foreign materials
    www.medline.com
    1-800-MEDLINE (633-5463)
    REF: MDS098014
    V1 RE22VJO

  • Package Label

    Label V1 RE22VJO

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-980
    Route of AdministrationTOPICAL, ORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-980-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/11/2015
    2NDC:53329-980-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/11/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00308/11/2015
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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