Label: ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT- sodium fluoride rinse

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

Drug Label Information

Updated October 20, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.02% (0.009% 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 twice a day after brushing your teeth with a toothpaste
    • remove cap
    • pour 10 milliliters (10 mL mark on inside of cap); do not fill above 10 mL mark
    • 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

    water, sorbitol, poloxamer 407, propylene glycol, menthol, methyl salicylate, sodium phosphate, disodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, flavor, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, blue 1, yellow 5

    Learn more at www. ACTFLUORIDE.com

  • PRINCIPAL DISPLAY PANEL

    #1 DENTIST RECOMMENDED
    FLUORIDE BRAND
    ACT
    Anticavity
    Fluoride Mouthwash
    alcohol free
    FRESH MINT
    33.8 fl oz (1 L)

    PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND ACT Anticavity Fluoride Mouthwash alcohol free FRESH MINT 33.8 fl oz (1 L) PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND ACT Anticavity Fluoride Mouthwash alcohol free FRESH MINT 33.8 fl oz (1 L)

  • INGREDIENTS AND APPEARANCE
    ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0943
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.09 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE CALCIUM DISODIUM (UNII: 25IH6R4SGF)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0943-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02101/01/2012
    Labeler - Chattem, Inc. (003336013)
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