Label: ANTICAVITY FLUORIDE RINSE- 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 1, 2011

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  • ACTIVE INGREDIENT

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

    Purpose
    Anticavity rinse
  • INDICATIONS & USAGE

    Use aids in the prevention of dental cavities
  • WARNINGS

    Warning

    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.
  • DOSAGE & ADMINISTRATION

    Directions
    • adults and children 6 years of age and older: use once a day after brushing your teeth with a toothpaste
    • remove cap
    • pour 10 milliliters (10 mL mark on the inside of cap); do not fill above the 10 mL mark
    • vigorously swish 10 milliliters of rinse between your teeth for 1 minute 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
  • STORAGE AND HANDLING

    Other information • store at room temperature
  • INACTIVE INGREDIENT

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

    This product is not manufactured or distributed by Chattem, Inc., distributor of Act Anticavity Fluoride Rinse
  • ADVERSE REACTIONS

    DISTRIBUTED BY: SUPERVALU INC.
    EDEN PRAIRIE, MN 55344 USA
    PRODUCT OF USE
    CONTACT US AT 1-877-932-7948, OR
    www.supervalu-ourownbrands.com
  • PRINCIPAL DISPLAY PANEL

    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
    equaline
    compare to
    ACT
    alcohol free
    anti
    cavity
    fluoride rinse
    •helps prevent cavities
    •strengthens teeth
    •freshens breath
    IMPORTANT: READ DIRECTINS FOR PROPER USE
    mint
    18 FL OZ
    (532 mL)
    image of principal display panel

  • INGREDIENTS AND APPEARANCE
    ANTICAVITY FLUORIDE RINSE 
    sodium fluoride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-213
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.05 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-213-44.532 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/14/2009
    Labeler - Supervalu, Inc (006961411)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture