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ACT Total Care Anticavity Fluoride Fresh Mint 2X (Chattem, Inc.)

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RINSE 1000 mL in 1 BOTTLE, PLASTIC (41167-0962-4) Label Information

Complete ACT Total Care Anticavity Fluoride Fresh Mint 2X Information

  • 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, green 3, yellow 5 (309-040)

    Learn more at www. ACTFLUORIDE.com


  • PRINCIPAL DISPLAY PANEL

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

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


  • INGREDIENTS AND APPEARANCE
    ACT ANTICAVITY FLUORIDE MINT 
    sodium fluoride rinse
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0962
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.09 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    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)  
    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
    Color GREEN Score     
    Shape Size
    Flavor MINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0962-4 1000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 02/01/2009
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    VI-JON, INC. 790752542 MANUFACTURE(41167-0962)