Label: MEDLINE PEROXI FRESH MOUTHWASH- hydrogen peroxide mouthwash mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 6, 2023

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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

    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

    If more than used for rinsing is accidentally swallowed, get medical hep or contact Poison Control Center right away

  • Directions

    -Adults and children 2 years of age or over: swish around in mouth over affected afrea for at least 1 minute and then spit out. Use up to 4 times daily after meals and at bedtime or as directed by 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

  • Label

    Entire Label

  • INGREDIENTS AND APPEARANCE
    MEDLINE PEROXI FRESH MOUTHWASH 
    hydrogen peroxide mouthwash mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83062-086(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)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83062-086-957 mL in 1 BOTTLE; Type 0: Not a Combination Product10/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/06/2023
    Labeler - IIMED MEDICAL MEXICANA S DE RL DE CV (812894376)
    Registrant - Team Technologies (192339703)
    Establishment
    NameAddressID/FEIBusiness Operations
    IIMED MEDICAL MEXICANA S DE RL DE CV812894376repack(83062-086) , relabel(83062-086)
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