LISTERINE ESSENTIAL CARE TARTAR CONTROL- sodium monofluorophosphate gel, dentifrice 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, 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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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
  • chidren 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, menthol, zinc citrate, 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
TARTAR CONTROL GEL

FRESHENS BREATH
THE LISTERINE WAY

POWERFUL MINT GEL

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 TARTAR CONTROL 
sodium monofluorophosphate gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42002-412
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (Fluoride Ion) Sodium Monofluorophosphate7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
Water 
Hydrated Silica 
Glycerin 
POLYETHYLENE GLYCOL 1500 
Sodium Lauryl Sulfate 
Carboxymethylcellulose Sodium 
Saccharin Sodium Dihydrate 
Eucalyptol 
Methyl Salicylate 
Thymol 
Phosphoric Acid 
Menthol 
Zinc Citrate 
Sodium Phosphate 
Xanthan Gum 
Benzoic Acid 
FD&C Blue No. 1 
D&C Yellow No. 10 
Packaging
#Item CodePackage Description
1NDC:42002-412-091 in 1 CARTON
1119 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/12/2012
Labeler - Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc. (831417154)

Revised: 03/2012
Document Id: e5d20655-9f5c-4afe-b770-764dfabffb6e
Set id: 7114f48a-7da4-4e8d-80f8-bc8ce46193bc
Version: 1
Effective Time: 20120313
 
Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.