Label: ACT KIDS ANTICAVITY FLUORIDE GROOVY GRAPE- sodium fluoride paste, dentifrice

  • 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

    Groovy Grape

    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 the 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 olderbrush 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 ageinstruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision.
    children under 2 years of ageconsult a dentist or doctor
  • Inactive ingredients

    water, sorbitol, hydrated silica, hydroxyethylcellulose, flavor, sucralose, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, red 33, blue 1

  • PRINCIPAL DISPLAY PANEL

    ACT
    Kids
    NEW
    ANTICAVITY
    FLUORIDE
    TOOTHPASTE
    GROOVY
    Grape
    NET WT 4.6 OZ (130 g)

    ACT Kids NEW ANTICAVITY FLUORIDE TOOTHPASTE GROOVY Grape NET WT 4.6 OZ (130 g)

  • INGREDIENTS AND APPEARANCE
    ACT KIDS ANTICAVITY FLUORIDE GROOVY GRAPE 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0926
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    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)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0926-1130 g in 1 TUBE; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/2021
    Labeler - Chattem, Inc. (003336013)
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