Label: ACT KIDS PURE PROTECT ANTICAVITY- SIMPLY STRAWBERRY- sodium fluoride rinse

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

Drug Label Information

Updated January 8, 2024

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  • SPL UNCLASSIFIED SECTION

    ACT Kids Pure Protect Anticavity Mouthwash

    Drug Facts

  • Active ingredients

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

  • Purpose

    Anticavity

  • Uses

    ■ 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 (10mL)
    • 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

    cetylpyridinium chloride, dipotassium glycyrrhizinate, disodium phosphate, flavor, glycerin, poloxamer 407, polysorbate 20, propylene glycol, sodium benzoate, sodium phosphate, sorbitol, stevia rebaudiana leaf/stem extract, water, xylitol

  • PRINCIPAL DISPLAY PANEL

    ACT
    Kids
    Anticavity
    Fluoride Rinse
    Simply
    Strawberry
    16.9 fl oz (500 mL)

    PRINCIPAL DISPLAY PANEL ACT Kids Anticavity Fluoride Rinse Simply Strawberry 16.9 fl oz (500 mL)

    PRINCIPAL DISPLAY PANEL ACT Kids Anticavity Fluoride Rinse Simply Strawberry 16.9 fl oz (500 mL)

  • INGREDIENTS AND APPEARANCE
    ACT KIDS PURE PROTECT ANTICAVITY- SIMPLY STRAWBERRY 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0915
    Route of AdministrationORAL
    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
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SORBITOL (UNII: 506T60A25R)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSTRAWBERRYImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0915-0500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/04/2024
    Labeler - Chattem, Inc. (003336013)
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