Label: ANTICAVITY- sodium fluoride rinse

  • NDC Code(s): 55910-030-44, 55910-030-77
  • Packager: Old East Main Co
  • 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 September 7, 2023

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  • 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, see 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 a toothpaste
    • 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

    • store at room temperture
  • Inactive ingredients

    benzyl alcohol, calcium disodium EDTA, cetylpyridinium chloride, disodium EDTA, disodium phosphate, flavor, poloxamer 407, polysorbate 80, propylene glycol, red 33, sodium benzoate, sodium phosphate, sodium saccharin, sorbitol, water

  • Adverse Reaction

    Sealed with printed neckband for your protection

    Visit us at: Rexall.com or call 1-866-4-REXALL

    DISTRIBUTED BY Old East Main CO,

    100 MISSION RIDGE

    GOODLETTSVILLE, TN 37072

    Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

  • Principal display panel

    DG health

    Compare to Act Bubblegum Blowout

    Anticavity Kids Fluoride Rinse

    KIDS

    Anticavity Fluoride Rinse

    Strong Cavity Protection

    Helps Strengthen Teeth

    Alcohol Free

    IMPORTANT: Read directions for proper use

    Bubblegum Flavor

    16.9 FL OZ

    (500 mL)

    image description

  • Principal display panel

    Since 1903

    Rexall

    kids

    Anticavity

    Fluoride Rinse

    Anticavitvy Fluoride Rinse

    • Helps prevent cavities
    • Helps strengthen teeth
    • Alcohol free

    IMPORTANT: read directions for proper use.

    ADA Accepted

    America Dental Association

    Helps Prevent cavities

    Bubblegum Flavor

    500 mL (1 PT 0.9 FL OZ) 16.9 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sodium fluoride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-030
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE CALCIUM DISODIUM ANHYDROUS (UNII: 8U5D034955)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-030-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2015
    2NDC:55910-030-44532 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/24/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35502/24/2015
    Labeler - Old East Main Co (068331990)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55910-030)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55910-030)
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