Home > Drugs A-Z > ACT Restoring Anticavity Fluoride Cool Splash Vanilla Mint

ACT Restoring Anticavity Fluoride Cool Splash Vanilla Mint (Chattem, Inc.)

Available Formats

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MOUTHWASH 532 mL in 1 BOTTLE, PLASTIC (41167-0977-0) Label Information

Complete ACT Restoring Anticavity Fluoride Cool Splash Vanilla 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
    • 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

    • 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 (245-168)

    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

    cool splashTM
    vanilla mint

    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 0.05%

    IMPORTANT: Read

    directions for proper use.

    18 fl oz (532
    mL)

    PRINCIPAL DISPLAY PANEL
ACT Restoring Anticavity Fluoride Mouthwash Cool Splash Vanilla Mint


  • INGREDIENTS AND APPEARANCE
    ACT RESTORING ANTICAVITY FLUORIDE COOL SPLASH VANILLA MINT 
    sodium fluoride mouthwash
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:41167-0977
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.5 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)  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor VANILLA Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:41167-0977-0 532 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part355 08/01/2006
    Labeler - Chattem, Inc. (003336013)
    Establishment
    Name Address ID/FEI Business Operations
    Access Business Group LLC 839830713 MANUFACTURE