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ACT Anticavity Fluoride Fresh Mint (Chattem, Inc.)

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Dosage Form Package Information Links
RINSE 532 mL in 1 BOTTLE, DISPENSING (41167-0942-8) Label Information

Complete ACT Anticavity Fluoride Fresh Mint Information

  • 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, menthol, methyl salicylate, sodium phosphate, potassium sorbate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, calcium disodium EDTA, sodium benzoate, green 3, yellow 5 (309-039)

    Learn more at www.ACTFLUORIDE.com


  • PRINCIPAL DISPLAY PANEL

    #1 DENTIST RECOMMENDED
    FLUORIDE BRAND

    ACT

    Anticavity
    Fluoride Mouthwash

    alcohol free

    MINT

    18 fl oz (532 mL)

    #1 DENTIST RECOMMENDED
FLUORIDE BRAND
ACT
Anticavity
Fluoride Mouthwash
alcohol free
MINT
18 fl oz (532 mL)


  • INGREDIENTS AND APPEARANCE
    ACT ANTICAVITY FLUORIDE MINT 
    sodium fluoride rinse
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0942
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.2 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)  
    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:41167-0942-1 30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/1994
    2 NDC:41167-0942-3 88 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/01/1994 03/15/2011
    3 NDC:41167-0942-8 532 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 04/01/1994
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 04/01/1994
    Labeler - Chattem, Inc. (003336013)