Label: ACT ANTICAVITY FLUORIDE KIDS GROOVY GRAPE- sodium fluoride rinse

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

Drug Label Information

Updated June 1, 2024

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  • SPL UNCLASSIFIED SECTION

    ACT

    Anticavity Kids Rinse Groovy Grape 0.05%

    Drug Facts

  • 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 accidentally swallowed, get medical help or contact a 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

    ■ do not use if safety seal is broken or missing

  • Inactive ingredients

    benzyl alcohol, blue 1, calcium disodium EDTA, cetylpyridinium chloride, disodium phosphate, flavor, poloxamer 407, polysorbate 20, potassium sorbate, propylene glycol, red 33, sodium benzoate, sodium phosphate, sorbitol, sucralose, water

  • PRINCIPAL DISPLAY PANEL

    ACT
    Kids
    ANTICAVITY
    FLUORIDE RINSE
    GROOVY GRAPE
    16.9 fl oz (500 mL)

    ACT Kids ANTICAVITY FLUORIDE RINSE GROOVY GRAPE 16.9 fl oz (500 mL)

  • INGREDIENTS AND APPEARANCE
    ACT ANTICAVITY FLUORIDE KIDS GROOVY GRAPE 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0945
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0945-0500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/01/2019
    Labeler - Chattem, Inc. (003336013)
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