Label: ACT ANTICAVITY FLUORIDE CINNAMON- sodium fluoride rinse

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

Drug Label Information

Updated October 9, 2023

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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
    • pour out. Only the correct 10 milliliters dose will pour out.
    • 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, disodium phosphate, polysorbate 80, sodium saccharin, flavor, cetylpridinium chloride, calcium disodium EDTA, benzyl alcohol, sodium benzoate, red 33, yellow 5 (309-098)

    Learn more at www.ACTFLUORIDE.com 

  • PRINCIPAL DISPLAY PANEL

    #1 DENTIST RECOMMENDED
    FLUORIDE BRAND
    ACT
    Anitcavity
    Fluoride Mouthwash
    alcohol free
    CINNAMON
    18 fl. oz. (532 mL)

    PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND ACT Anitcavity Fluoride Mouthwash alcohol free CINNAMON 18 fl. oz. (532 mL) PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND ACT Anitcavity Fluoride Mouthwash alcohol free CINNAMON 18 fl. oz. (532 mL)

  • INGREDIENTS AND APPEARANCE
    ACT ANTICAVITY FLUORIDE CINNAMON 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0940
    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)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorCINNAMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0940-8532 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/01/1994
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02104/01/1994
    Labeler - Chattem, Inc. (003336013)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHATTEM, INC.832973031manufacture(41167-0940)
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