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
  • Marketing Status: OTC monograph not 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 March 14, 2022

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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 not finalpart35601/01/2007
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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