Label: ACT KIDS ANTICAVITY FLUORIDE WILD WATERMELON- sodium fluoride rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2023

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  • SPL UNCLASSIFIED SECTION

    ACT® Anticavity Wild Watermelon

    Fluoride Rinse

  • Active ingredient

    Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

  • Purpose

    Anticavity  

  • Use

    • aids in the prevention of dental cavities
  • Warnings

    Keep out of reach of children.

    If more than used for rinsing is accidently swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    adults and children 6 years of age and older:

    • use once a day after brushing your teeth with a toothpaste
    • remove cap
    • hold bottle upright and squeeze. Fill to FILL LINE
    • pour out. Only the correct 10 milliliters dose will pour out
    • vigorously swish 10 milliliters of rinse 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 (to minimize swallowing)
    • supervise children as necessary until capable of using without supervision

    children under 6 years of age: consult a dentist or doctor.

  • Other Information

    • contains FD&C yellow no.5 (tartrazine) as a color additive
    • do not use if safety seal is broken or missing
  • Inactive ingredients

    calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, green 3, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, sucralose, water, yellow 5 (309-023)

  • Principal Display Panel

    ACT Kids
    Anticavity Fluoride Rinse
     Wild Watermelon
    Sodium Fluoride 0.05%
    16.9 fl oz (500 mL)

    ACT Kids Anticavity Fluoride Rinse Wild Watermelon Sodium Fluoride 0.05% 16.9 fl oz (500 mL)

  • INGREDIENTS AND APPEARANCE
    ACT KIDS ANTICAVITY FLUORIDE  WILD WATERMELON
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0938
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorWATERMELONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0938-1500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/01/2017
    Labeler - Chattem, Inc. (003336013)
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