Label: ORAL B MOUTH SORE SPECIAL CARE RINSE- sodium fluoride rinse

  • NDC Code(s): 37000-962-08, 37000-962-16
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2023

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrogen Peroxide 1.5%

  • Purpose

    oral debriding/wound cleansing

  • Uses

    • For temporary use in cleansing minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
    • Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.
    • For temporary use to cleanse canker sores.
  • Warnings

    • Do not use this product for more than 7 days unless directed by a dentist or doctor.
    • If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.

    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 6 yrs. & older:

    Rinse with 20 mL

    Swish around in the mouth over the affected area for at least 1 minute and then spit out.

    Use up to four times daily after meals and at bedtime or as directed by a dentist or doctor.

    do not swallow

    • children 6 years to under 12 years of age:

    supervise use

    • children under 6 years of age:

    do not use

  • Inactive ingredients

    citric acid, flavor, glycerin, poloxamer 407, propylene glycol, sodium citrate, sodium hexametaphosphate, sodium saccharin, sucralose, water

  • Questions?

    1-800-862-7442

  • SPL UNCLASSIFIED SECTION

    DISTR. BY ORAL-B, A DIVISION

    OF PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 475 mL Bottle Label

    Oral-B

    HYDROGEN PEROXIDE ORAL DEBRIDING AGENT

    MOUTH SORE

    SPECIAL CARE ORAL RINSE

    For Mouth Sores Including:

    • Canker Sores
    • Cheek Bites
    • Braces & Denture Irritations
    • Oral & Gum Irritations

    SOOTHING MINT

    475 mL (16 FL OZ)

    962

  • INGREDIENTS AND APPEARANCE
    ORAL B MOUTH SORE  SPECIAL CARE RINSE
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-962
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.03 mL  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-962-16475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2020
    2NDC:37000-962-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/02/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)