Label: PERCARA KIDS BUBBLE GUM- sodium fluoride rinse

  • NDC Code(s): 67933-0016-1
  • Packager: LEC Custom Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 1, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients

    Sodium fluoride 0.05% (Fluoride ion-0.0226%)

  • PURPOSE

    Purpose

    Anticavity rinse

  • INDICATIONS & USAGE

    Uses

    aids the prevention of dental cavities

  • WARNINGS

    Warning

    Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 6 years of age and older, use once a day after brushing your teeth with a toothpaste
    • Remove cap
    • Use approximately one tablespoon and rinse vigorously between your teeth for 1 minute and then spit out
    • do not swallow the rinse
    • do not eat or drink for 30 minutes after rinsing
    • instruct children under 12 years of age in good rinsing habits
    • supervise children as necessary until capable of using without supervision
    • children under 6 years of age: consult a dentist or doctor
  • INACTIVE INGREDIENT

    Inactive ingredients benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene plycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

  • SPL UNCLASSIFIED SECTION

    Other information

    • Store at room temperature
  • SPL UNCLASSIFIED SECTION

    Distributed by: LEC Custom Products, Inc, Missisauga, ON L5S 1B8

    MADE IN CANADA

  • PRINCIPAL DISPLAY PANEL

    PERCARA™

    ALCOHOL FREE

    CAVITY PROTECTION

    kids BUBBLE GUM

    FLUORIDE RINSE

    18 FL OZ (532 ML)PERCARA - Kids BG Fluoride Rinse

  • INGREDIENTS AND APPEARANCE
    PERCARA KIDS BUBBLE GUM 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67933-0016
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.05 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67933-0016-1532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02103/23/2021
    Labeler - LEC Custom Products, Inc. (204065726)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEC Custom Products, Inc204064757manufacture(67933-0016)
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