Label: ACT KIDS ANTICAVITY FLUORIDE BUBBLE GUM BLOWOUT- sodium fluoride paste

  • NDC Code(s): 41167-0922-2, 41167-0922-4
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • SPL UNCLASSIFIED SECTION

    ACT®  Kids 

    Anticavity Fluoride Toothpaste

    Bubblegum Blowout

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (0.14% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older:  brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
    • Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 as necessary and use a pea-sized amount until your child is capable of using without supervision.
    • children under 2 years of age:  do not use unless directed by a dentist or doctor
  • Inactive ingredients

    water, sorbitol, hydrated silica, hydroxyethylcellulose, sucralose, flavor, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, red 33

  • PRINCIPAL DISPLAY PANEL

    ACT
    Kids
    BUBBLE
    GUM
    BLOWOUT
    NET WT 4.6 oz (130 g)

    ACT Kids BUBBLE GUM BLOWOUT NET WT 4.6 oz (130 g)

  • INGREDIENTS AND APPEARANCE
    ACT KIDS ANTICAVITY FLUORIDE  BUBBLE GUM BLOWOUT
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0922
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0922-2130 g in 1 TUBE; Type 0: Not a Combination Product11/01/2016
    2NDC:41167-0922-411 g in 1 TUBE; Type 0: Not a Combination Product11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/01/2016
    Labeler - Chattem, Inc. (003336013)
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