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ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint 2X (Chattem, Inc.)

Available Formats

Dosage Form Package Information Links
MOUTHWASH 1000 mL in 1 BOTTLE, PLASTIC (41167-0980-6) Label Information

Complete ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint 2X Information

  • 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 into cap (10 mL is equal to 2 teaspoonfuls); do not use more than 10 milliliters
    • 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

    • do not use if safety seal is broken or missing

  • Inactive ingredients

    water, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, green 3, yellow 10 (245-173)

    www.actfluoride.com

    ACT® RESTORINGTM

    Anticavity Mouthwash

    • Restores essential
      minerals to soft spots

    • Strengthens enamel to
      help prevent tooth decay

    • Kills bad breath germs

    CHATTEM®
    Dist. by CHATTEM, INC.
    P.O. Box 2219
    Chattanooga, TN 37409 USA
    © 2007 Chattem, Inc.

    Patent Pending

    *among fluoride mouth rinses

    Bottle configuration
    is a trademark of
    Signal Investment &
    Management Co.


  • PRINCIPAL DISPLAY PANEL

    use
    2X

    a day

    see directions

    cool
    splashTM
    spearmint

    ACT
    ®
    RestoringTM
    ANTICAVITY FLUORIDE

    mouthwash

    RESTORES

    minerals to soft spots

    STRENGTHENS

    enamel to prevent

    tooth decay

    KILLS

    bad breath germs

    #1 DENTIST RECOMMENDED BRAND*

    Sodium Fluoride 0.02%

    IMPORTANT: Read directions for proper use.

    33.8 fl oz (1000
    mL)

    PRINCIPAL DISPLAY PANEL
ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Spearmint 2X


  • INGREDIENTS AND APPEARANCE
    ACT RESTORING ANTICAVITY FLUORIDE MOUTHWASH COOL SPLASH SPEARMINT 2X 
    sodium fluoride mouthwash
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0980
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor SPEARMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0980-6 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 02/01/2006
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Chattem Plant 3 832973031 MANUFACTURE, PACK