Label: ACT WHITENING ANTICAVITY GENTLE MINT (sodium fluoride 0.02- 0.009 w/v fluoride ion mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 1, 2019

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  • SPL UNCLASSIFIED SECTION

    ACT Whitening

    Anticavity Gentle Mint 

    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

    Stop use and ask a dentist if

    oral irritation or tooth sensitivity occurs

    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 12 years of age and older:

    ■ use twice a day after brushing your teeth with a toothpaste  

    ■ vigorously swish 10 milliliters (2 teaspoonfuls) 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

    ■ supervise children as necessary until capable of using without supervision

    children under 12 years of age: consult a dentist or doctor

  • Other information

    ■ do not use if safety seal is broken or missing

  • Inactive ingredients

    water, glycerin, xylitol, hydrogen peroxide, poloxamer 407, propylene glycol, pentylene glycol, flavors, sodium benzoate, sodium phosphate, disodium phosphate, 4-t-butylcyclohexanol, menthol, sucralose, sodium saccharin, calcium disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    ACT
    WHITENING
    ANTICAVITY FLUORIDE MOUTHWASH
    GENTLE MINT
    16.9 fl oz (500 mL)

    PRINCIPAL DISPLAY PANEL
ACT
WHITENING
ANTICAVITY FLUORIDE MOUTHWASH
GENTLE MINT
16.9 fl oz (500 mL)
 PRINCIPAL DISPLAY PANEL
ACT
WHITENING
ANTICAVITY FLUORIDE MOUTHWASH
GENTLE MINT
16.9 fl oz (500 mL)

  • INGREDIENTS AND APPEARANCE
    ACT WHITENING ANTICAVITY GENTLE MINT 
    sodium fluoride 0.02 (0.009 w/v fluoride ion) mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0983
    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)  
    XYLITOL (UNII: VCQ006KQ1E)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    4-TERT-BUTYLCYCLOHEXANOL (UNII: K0H1405S9C)  
    MENTHOL (UNII: L7T10EIP3A)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-0983-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35503/01/2019
    Labeler - Chattem, Inc. (003336013)