Label: ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH- sodium fluoride rinse

  • NDC Code(s): 41167-0968-0, 41167-0968-3, 41167-0968-5, 41167-0968-9
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • 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

    • do not use if safety seal is broken or missing
  • Inactive ingredients

    water, glycerin, sorbitol, xylitol, poloxamer 407, betaine, propylene glycol, flavors, bisabolol, carnosine, PEG-14M, PEG-160M, zingiber officinale (ginger) root extract, angelica polymorpha sinensis root extract, lonicera japonica (honeysuckle) flower extract, pueraria lobata root extract, sodium benzoate, potassium sorbate, sodium phosphate, disodium phosphate, polysorbate 20, lactic acid, calcium disodium EDTA, cetylpyridinium chloride, sucralose, green 3, yellow 10 (309-043)

    Learn more at www.ACTFLUORIDE.com

  • PRINCIPAL DISPLAY PANEL

    #1 DENTIST RECOMMENDED
    FLUORIDE BRAND
    ACT    ® TOTAL CARE
    ANTICAVITY FLUORIDE RINSE
    DRY MOUTH
    ● SOOTHES Dry Mouth
    ● MOISTURIZES Mouth Tissue
    ● STRENGTHENS Teeth
    ● FRESHENS Breath
    Sodium Fluoride 0.02%
    18 fl oz (532 mL)

    PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND ACT® TOTAL CARE ANTICAVITY FLUORIDE RINSE DRY MOUTH ● SOOTHES Dry Mouth ● MOISTURIZES Mouth Tissue ● STRENGTHENS Teeth ● FRESHENS Breath Sodium Fluoride 0.02% 18 fl oz (532 mL)

    PRINCIPAL DISPLAY PANEL #1 DENTIST RECOMMENDED FLUORIDE BRAND ACT® TOTAL CARE ANTICAVITY FLUORIDE RINSE DRY MOUTH ● SOOTHES Dry Mouth ● MOISTURIZES Mouth Tissue ● STRENGTHENS Teeth ● FRESHENS Breath Sodium Fluoride 0.02% 18 fl oz (532 mL)

  • INGREDIENTS AND APPEARANCE
    ACT TOTAL CARE DRY MOUTH ANTICAVITY MOUTH 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0968
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.09 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BETAINE (UNII: 3SCV180C9W)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)  
    POLYETHYLENE OXIDE 7000000 (UNII: G3MS6M810Y)  
    GINGER (UNII: C5529G5JPQ)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    PUERARIA MONTANA VAR. CHINENSIS ROOT (UNII: FQN0D1U235)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    DISODIUM PHOSPHATE (UNII: 22ADO53M6F)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0968-588 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
    2NDC:41167-0968-0532 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
    3NDC:41167-0968-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
    4NDC:41167-0968-930 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/01/2011
    Labeler - Chattem, Inc. (003336013)
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