LISTERINE ESSENTIAL CARE- sodium monofluorophosphate gel, 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 ® FLUORIDE ANTICAVITY TOOTHPASTE ORIGINAL GEL

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
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
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)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42002-411-091 in 1 CARTON03/12/201209/24/2022
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 finalpart35503/12/201209/24/2022
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 9/2021
 
Johnson & Johnson Consumer Inc.