Label: ACT ANTICAVITY FLUORIDE KIDS WILD WATERMELON (sodium fluoride 0.24- 0.14 w/v fluoride ion paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 21, 2019

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  • SPL UNCLASSIFIED SECTION

    ACT

    Kids Anticavity Fluoride Toothpaste

    (Wild Watermelon)

         

    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 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 agedo not use unless directed by a dentist or doctor
  • Other information

    contains FD&C yellow no. 5 (tartrazine) as a color additive

  • Inactive ingredients

    water, sorbitol, hydrated silica, hydroxyethylcellulose, flavor, sucralose, benzoic acid, sodium saccharin, potassium hydroxide, sodium benzoate, dipotassium glycyrrhizate, sodium lauryl sulfate, yellow 5, green 3

  • PRINCIPAL DISPLAY PANEL

    ACT
    Kids
    wild
    water-
    melon
    NET WT 4.6 oz (130 g)

    PRINCIPAL DISPLAY PANEL
ACT
Kids
wild
water-
melon
NET WT 4.6 oz (130 g)

  • INGREDIENTS AND APPEARANCE
    ACT ANTICAVITY FLUORIDE KIDS WILD WATERMELON 
    sodium fluoride 0.24 (0.14 w/v fluoride ion) paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0924
    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)  
    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)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0924-2130 g in 1 TUBE; Type 0: Not a Combination Product05/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35505/21/2019
    Labeler - Chattem, Inc. (003336013)