Label: ACT ANTICAVITY FLUORIDE MINT- sodium fluoride rinse

  • NDC Code(s): 41167-0942-1, 41167-0942-3, 41167-0942-8
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 1, 2024

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  • SPL UNCLASSIFIED SECTION

    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 (10 mL)
    • 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, green 3, yellow 5

    Learn more at www.ACTFLUORIDE.com

  • PRINCIPAL DISPLAY PANEL

    ZERO ALCOHOL
    #1 DENTIST RECOMMENDED
    FLUORIDE BRAND

    ACT

    1X Daily

    ANTICAVITY

    FLUORIDE MOUTHWASH

    MINT

    18
    fl oz (532 mL)

    ZERO ALCOHOL
#1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
1X Daily
ANTICAVITY
FLUORIDE MOUTHWASH
MINT
18 fl oz (532 mL)

  • INGREDIENTS AND APPEARANCE
    ACT ANTICAVITY FLUORIDE MINT 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0942
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MINT (UNII: FV98Z8GITP)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0942-8532 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/01/1994
    2NDC:41167-0942-130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/1994
    3NDC:41167-0942-388 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/199403/15/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/01/1994
    Labeler - Chattem, Inc. (003336013)