Label: FLUORIDE MOUTH RINSE ANTICAVITY- sodium fluoride mouthwash

  • NDC Code(s): 11673-213-44, 11673-213-77
  • Packager: Target Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 7, 2023

If you are a consumer or patient please visit this version.

  • Tamper Evident Statment

    Sealed with printed neckband for your protection

  • Active ingredient

    Sodium fluoride 0.05% (0.02% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

    for this product

  • Keep out of reach of children.

    If more than used for rinsing is accidentally swallowed, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Adults and children 6 years of age and older:

    • use once a day after brushing your teeth with toothpaste
    • vigorously swish 10 milliliters of rinse between your teeth for 1 minute then spit it 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

    • store at room temperature
  • Inactive ingredients

    water, sorbitol, menthol, methyl salicylate, flavor, cetylpyridinium chloride, sodium saccharin, poloxamer 407, polysorbate 20, propylene glycol, sodium phosphate, disodium phosphate, calcium disodium EDTA, disodium EDTA, sodium benzoate, potassium sorbate, benzyl alcohol, green 3, yellow 5

  • SPL UNCLASSIFIED SECTION

    Distributed by Target Corporation

    mINNEAPOLIS, mn 55403

    Made in THE U.S. with U.S. and foreign components

    TM & ©2024 Target Brands, Inc.

    Guest Servies 1-800-910-6874

  • Principal display panel

    Anticavity Oral Rinse

    Alcohol Freewith Fluoride

    Mint

    ADA Accepted

    America Dental Association

    IMPORTANT: read directions for proper use

    • Helps strengthen enamel
    • Freshens breath

    up & up

    16.9 fl oz (1.05 PT) 500mL

    image description

  • INGREDIENTS AND APPEARANCE
    FLUORIDE MOUTH RINSE ANTICAVITY 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-213
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-213-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2010
    2NDC:11673-213-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/17/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02108/17/2010
    Labeler - Target Corp. (006961700)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11673-213)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11673-213)