Label: ACT RESTORING ANTICAVITY FLUORIDE MINT BURST- sodium fluoride mouthwash

  • NDC Code(s): 41167-0979-0, 41167-0979-1, 41167-0979-3
  • 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

    ACT® Restoring™ Mint Burst

    Anticavity Fluoride Rinse

    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
    • pour 10 milliliters into cap (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, sodium phosphate, polysorbate 20, sodium saccharin, sucralose, disodium phosphate, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, potassium sorbate, flavor, yellow 5, green 3 (309-166)

  • PRINCIPAL DISPLAY PANEL

    ZERO ALCOHOL
    ACT
    1X Daily
    RESTORING 
    ANTICAVITY FLUORIDE MOUTHWASH
    MINT BURST
    18 fl oz (532 mL)

    ZERO ALCOHOL ACT 1X Daily RESTORING ANTICAVITY FLUORIDE MOUTHWASH MINT BURST 18 fl oz (532 mL)

  • INGREDIENTS AND APPEARANCE
    ACT RESTORING ANTICAVITY FLUORIDE MINT BURST 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0979
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0979-0532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/16/2015
    2NDC:41167-0979-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/16/2015
    3NDC:41167-0979-388 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02112/16/2015
    Labeler - Chattem, Inc. (003336013)
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