Label: LISTERINE ESSENTIAL CARE- sodium monofluorophosphate gel, dentifrice

  • NDC Code(s): 42002-411-09
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 18, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium monofluorophosphate 0.76% (0.13% w/v fluoride ion)

  • Purpose

    Anticavity

  • Use

    aids in the prevention of dental cavities

  • Warnings

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least 2 times a day, or as directed by a dentist or physician.
      • children 2-6 years use a pea sized amount
      • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing)
      • supervise children as necessary until capable of using without supervision.
    • children under 2 years of age: ask a dentist or doctor
  • Other information

    • Store at Room Temperature.
  • Inactive ingredients

    water, sorbitol, hydrated silica, glycerin, PEG-32, sodium lauryl sulfate, cellulose gum, sodium saccharin, eucalyptol, methyl salicylate, thymol, phosphoric acid, menthol, sodium phosphate, xanthan gum, benzoic acid, flavor, mentha viridis (spearmint) leaf oil, disodium phosphate, blue 1, yellow 10

  • Questions?

    call toll-free 888-222-0182 or 215-273-8755 (collect)

  • PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

    LISTERINE®
    ESSENTIAL CARE®

    FLUORIDE ANTICAVITY TOOTHPASTE
    ORIGINAL GEL

    POWERFUL MINT GEL

    FRESHENS BREATH
    THE LISTERINE® WAY

    Kills the Germs
    That Cause Bad Breath
    Helps Prevent Cavities
    Removes Stains

    NET WT. 4.2 OZ. (119 g)

    Principal Display Panel - 119 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    LISTERINE ESSENTIAL CARE 
    sodium monofluorophosphate gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-411
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Glycerin (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Eucalyptol (UNII: RV6J6604TK)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Thymol (UNII: 3J50XA376E)  
    Phosphoric Acid (UNII: E4GA8884NN)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Sodium Phosphate (UNII: SE337SVY37)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    MENTHA SPICATA OIL (UNII: C3M81465G5)  
    Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)  
    Fd&C Blue No. 1 (UNII: H3R47K3TBD)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42002-411-091 in 1 CARTON03/12/2012
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35503/12/2012
    Labeler - Johnson & Johnson Consumer Inc. (002347102)