LISTERINE ESSENTIAL CARE- sodium monofluorophosphate paste, dentifrice 
Johnson & Johnson Consumer Inc.

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.

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Listerine Essential Care Toothpaste

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 brushing is accidentally 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 only a pea size amount
  • Instruct children under 12 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 (59° - 77°F)

Inactive ingredients

sorbitol solution, water, hydrated silica, glycerin, PEG-32, sodium lauryl sulfate, cellulose gum, sodium saccharin, eucalyptol, methyl salicylate, thymol, phosphoric acid, titanium dioxide, menthol, sodium phosphate, xanthan gum, benzoic acid, flavors, FD&C blue no. 1, D&C yellow no. 10

Questions?

US/Canada, 888-222-0182; Outside US/Canada, dial collect 215-273-8755

Dist: Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc., Skillman, NJ 08558-9418 USA

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

NEW LOOK, SAME GREAT FORMULA
LISTERINE®
ESSENTIAL CARE®
FLUORIDE ANTICAVITY TOOTHPASTE
ORIGINAL PASTE

FRESHENS BREATH
THE LISTERINE WAY

POWERFUL MINT PASTE

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

NET WT. 4.2 OZ. (119g)

Principal Display Panel - 119 g Tube Carton
LISTERINE ESSENTIAL CARE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-413
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
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Glycerin (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 1500 (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)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
Sodium Phosphate (UNII: SE337SVY37)  
Xanthan Gum (UNII: TTV12P4NEE)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
FD&C Blue No. 1 (UNII: H3R47K3TBD)  
D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-413-091 in 1 CARTON03/12/201207/20/2016
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 FINALpart35503/12/201207/20/2016
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 7/2016
 
Johnson & Johnson Consumer Inc.