Label: ANTICAVITY- sdoium 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 March 26, 2012

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  • ACTIVE INGREDIENT

    Active ingredients
    Sodium fluoride 0.221%(0.021% w/v fluoride ion)

    Purpose
    Anticavity
  • INDICATIONS & USAGE

    Use aids in the prevention of dental cavities
  • WARNINGS

    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.
  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children 12 years of age and older:
    •use twice daily 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
    •supervise children as necessary until capable of using without supervision
    •children under 12 years of age: consult a dents or doctor
  • STORAGE AND HANDLING

    Other information
    •store at controlled room temperature 20⁰ - 25⁰ C (68⁰ - 77⁰F)
    •cold weather may temporarily cloud this product
  • INACTIVE INGREDIENT

    Inactive ingredients water, sorbitol solution; alcohol (21.6%), flavors, poloxamer 407, sodium lauryl sulfate, phosphoric acid, sucralose and /or sodium saccharin,
    diabasic sodium phosphate, D+C red no.33, FD+C blue no.1, FD+C yellow no.6
  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine Total Care
    DSP-TN-15000
    DSP-MO-34
    SDS-TN-15012
  • ADVERSE REACTIONS

    DISTRIBUTED BY
    ONPOINT, INC
    2 PARAGON DRIVE
    MONTVALE, NJ 07645
  • PRINCIPAL DISPLAY PANEL

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
    Live Better
    Anticavity
    Mouthwash
    Sodium Fluoride and Acidulated
    Phosphate Topical Solution
    ICE MINT
    Compare to Active Ingredients in Listerine Total Care
    •HELPS PREVENT CAVITIES
    •RESTORES ENAMEL
    •HELPS STRENGTHEN TEETH
    •HELPS KILL GERMS THAT CAUSE BAD BREATH
    •FRESHENS BREATH
    IMPORTANT: READ DIRECTIONS FOR PROPER USE.
    1L (33.8 FL OZ)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    ANTICAVITY 
    sdoium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51143-966
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE.0221 mL  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51143-966-861 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35503/21/2012
    Labeler - Onpoint, Inc (001367366)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture
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