Label: ANTICAVITY FLUORIDE- sodium fluoride 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 January 30, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Fluoride 0.02% (0.01% 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.

    Vigorously swish 10 mL (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.

    Instruct children 12 years of age in good rinsing habits (to minimize swallowing).

    Supervise children as necessary until capable of using without supervision.

    Close cap fully after use, until the cap is felt to “click”, to reengage the child resistant cap.

    Children under 6 years of age: Consult a dentist or doctor

  • Other information

    Store at room temperature. Cold temperature may temporarily cloud this product.

  • Inactive ingredients

    water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, poloxamer 407, propylparaben, disodium phosphate, blue 1

    This rinse may cause temporary staining to the surface of teeth.

    This is not harmful and adequate brushing may prevent its occurrence.

  • PRINCIPAL DISPLAY PANEL

    Anticavity Fluoride
    Mouthwash
    Sodium Fluoride Oral Solution
    Minty Fresh
    33.8 FL OZ (1 L)

    PRINCIPAL DISPLAY PANEL Anticavity Fluoride Mouthwash Sodium Fluoride Oral Solution Minty Fresh 33.8 FL OZ (1 L)

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY FLUORIDE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-429
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-429-151000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/30/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35501/30/2017
    Labeler - CVS Pharmacy (062312574)
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