Label: PREOP- hydrogen peroxide rinse
PREOP- pre-treatment antiseptic rinse rinse

  • 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 8, 2021

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENT

    ​Active ingredient

    Hydrogen Peroxide 2.65%​​

  • PURPOSE

    Purpose

    antiseptic oral rinse

  • INDICATIONS & USAGE

    Uses

    • for dental procedural rinsing
    • to help prevent infection in minor oral irritations
  • WARNINGS

    Warnings

    Do not use this product for more than 7 days unless directed by a dentist or physician.

  • WHEN USING

    When using this product, do not swallow

  • STOP USE

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve within 7 days
    • irritations, 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: rinse two pumps (4-5 mL)
      around in the mouth over the affected area for at least 15 seconds, then spit out
    • 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 physician

  • OTHER SAFETY INFORMATION

    Other Informationstore at controlled room temperature 68-77°F (20 - 25°C)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Etidronic acid, glycerine, menthe arvensis oil, PEG, PVP, sodium benzoate, sodium

    citrate, sodium lauryl sulfate, sucralose, water

  • QUESTIONS

    Questions?  +1 (855) 595-2999

  • PRINCIPAL DISPLAY PANEL

    EverSmile

    PREOP​™

    PRE-TREATMENT

    ANTISEPTIC RINSE

    HYDROGEN PEROXIDE

    EXPANDING  FOAM

    16 FL OZ (475 mL)

    Manufactured by EverBrands, Inc

    401 N. Oak St., Inglewood, CA 90302

    eversmilewhite.com/preop

    +1 (855) 595-2999

    Mint

    PreOp_Mint_16oz

    Bubble Gum

    PreOp-BGum 16oz

    res

  • INGREDIENTS AND APPEARANCE
    PREOP 
    hydrogen peroxide rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72655-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE26.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETIDRONIC ACID (UNII: M2F465ROXU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72655-200-01475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/01/2021
    PREOP 
    pre-treatment antiseptic rinse rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72655-201
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE26.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETIDRONIC ACID (UNII: M2F465ROXU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72655-201-01475 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/01/2021
    Labeler - Everbrands, Inc. (080314845)
    Registrant - Everbrands, Inc. (080314845)
    Establishment
    NameAddressID/FEIBusiness Operations
    Everbrands, Inc.080314845manufacture(72655-200, 72655-201)
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