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

  • NDC Code(s): 41167-0961-0, 41167-0961-3, 41167-0961-4
  • Packager: Chattem, Inc.
  • 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

    ZERO ALCOHOL
    #1 DENTIST RECOMMENDED
    FLUORIDE BRAND
    ACT
    TOTAL CARE
    ANTICAVITY FLUORIDE MOUTHWASH
    FRESH MINT
    18 fl oz (532 mL)

    ZERO ALCOHOL #1 DENTIST RECOMMENDED FLUORIDE BRAND ACT TOTAL CARE ANTICAVITY FLUORIDE MOUTHWASH FRESH MINT 18 fl oz (532 mL)

  • INGREDIENTS AND APPEARANCE
    ACT TOTAL CARE ANTICAVITY FLUORIDE FRESH MINT 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0961
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0961-0532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2009
    2NDC:41167-0961-388 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/200902/17/2018
    3NDC:41167-0961-41900 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/200901/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/01/2009
    Labeler - Chattem, Inc. (003336013)
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