Label: PREVENTION MOUTH RINSE- hydrogen peroxide liquid

  • NDC Code(s): 69951-002-16
  • Packager: Prevention Health Sciences, Inc.
  • 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 October 1, 2023

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Hydrogen peroxide 1.5%

  • PURPOSE

    Purpose

    Oral debriding agent / Antiseptic

  • INDICATIONS & USAGE

    Uses

    • first aid to help reduce the risk of infection in minor cuts and scrapes caused by
    • dentures
    • dental procedures
    • orthodontic appliances
    • accidental injury
    • aids in the removal of phlegm, mucus or other secretions associated with occasional sore mouth
    • for temporary use to cleanse canker sores, minor wounds and gum irritation
  • Warnings

  • DO NOT USE

    Do not use for more than 7 days unless directed by a dentist or doctor

  • STOP USE

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve within 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash or fever develops
  • KEEP OUT OF REACH OF CHILDREN

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older: swish one capful (10 ml) around in mouth over affected area for at least one 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 should be supervised in the use of product.
    • children under 2 years of age: consult a dentist or doctor.
  • STORAGE AND HANDLING

    Other information

    • keep away from heat or direct sunlight
    • Do not use if safey seal under cap is broken or missing
  • INACTIVE INGREDIENT

    Inactive ingredients De-ionized water, glycerin, poloxamer 407, sodium lauryl sulfate, disodium EDTA, Mentha piperita (peppermint) oil, sodium citrate, sodium saccharin, citric acid, zinc chloride, menthol

  • QUESTIONS

    Questions? call (800) 473-1205

  • SPL UNCLASSIFIED SECTION

    Formulated and Distribured by:

    Prevention Health Sciences, Inc.

    Raleigh, IL 62977

    800-473-1205

    PHS Brands

  • PRINCIPAL DISPLAY PANEL

    ALCOHOL FREE

    PREVENTION™ MOUTH RINSE

    Formulated for MOUTH SORE RELIEF

    Oral Antiseptic for Healing of Common Mouth Sores

    • CANKER SORES
    • IRRITATION FROM BRACES
    • MINOR MOUTH INJURIES

    Soothing Mint

    NET. 16 FL OZ (1 PT) 473 ML

    label

  • INGREDIENTS AND APPEARANCE
    PREVENTION MOUTH RINSE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69951-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69951-002-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/01/2023
    Labeler - Prevention Health Sciences, Inc. (968930540)
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