Label: MEDLINE PEROXI FRESH MOUTHWASH- hydrogen peroxide mouthwash

  • NDC Code(s): 53329-086-13, 53329-086-14, 53329-086-66, 53329-086-95
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 26, 2024

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  • Active ingredient

    Hydrogen Peroxide 1.5%

  • Purpose

    Oral Debriding Agent

  • Use

    • aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth
  • Warnings


    Do not use this product

    • for more than 7 days unless directed by a dentist or physician.

    When using this product

    • do not swallow

    Stop use and ask a doctor if

    • 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 more than used for rinsing is accidentally swallowed, get medical help or contact a poison Control Center right away.

  • Directions

    • Adults and Children 2 Years of Age or Over: Swish around in mouth over affected area for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor.
    • Children Under 12 Years of Age: Should be supervised in the use of this product.
      Children Under 2 Years of Age: Consult a dentist or a doctor.
  • Other information

    • avoid excessive heat and protect from freezing
  • Inactive ingredients

    flavor, sodium lauryl sulfate, sodium saccharin, water

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MDS096065HP

    V1 RB22ANO

  • Package Label

    PDP

  • INGREDIENTS AND APPEARANCE
    MEDLINE PEROXI FRESH  MOUTHWASH
    hydrogen peroxide mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-086
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-086-1359 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/200712/31/2017
    2NDC:53329-086-6610 mL in 1 PACKET; Type 0: Not a Combination Product01/01/200707/31/2021
    3NDC:53329-086-1459 mL in 1 BOTTLE; Type 0: Not a Combination Product03/08/2017
    4NDC:53329-086-957 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/01/2007
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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