Listerine Whitening Fluoride Anticavity Toothpaste Original Gel

Drug Labeling and Warnings

Drug Details [pdf]

LISTERINE WHITENING FLUORIDE ANTICAVITY  ORIGINAL- 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.

----------

Listerine Whitening 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 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, menthol, zinc citrate, sodium phosphate, xanthan gum, benzoic acid, flavors, FD&C blue no. 1, D&C yellow no. 10

Questions?

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

PRINCIPAL DISPLAY PANEL - 119g Tube Carton

NEW

FOR A HEALTHY LOOKING WHITE SMILE

LISTERINE®
WHITENING®

fluoride anticavity toothpaste
original gel

VIBRANT WHITE® MINT

Whitens by removing
surface stains®

NET WT. 4.2 OZ. (119g)

LISTERINE WHITENING FLUORIDE ANTICAVITY   ORIGINAL
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-428
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Zinc Citrate (UNII: K72I3DEX9B)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-428-09	1 in 1 CARTON	11/12/2012	05/22/2017
1		119 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	11/12/2012	05/22/2017

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019

Document Id: 47de2e34-545c-4d8f-b469-9ebe228b3a51

34390-5

Set id: 0b378854-2304-4852-90b1-0b56c4b72e5d

Version: 2

Effective Time: 20190108