NDC Code(s) : 42002-507-96, 42002-507-95, 42002-507-73, 42002-507-72, 42002-507-71
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Listerine Total Care Zero Anticavity Sodium Fluoride MOUTHWASH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42002-507
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride(UNII: 8ZYQ1474W7)
(Fluoride Ion - UNII:Q80VPU408O) 		Fluoride Ion0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Sorbitol(UNII: 506T60A25R)
Propylene Glycol(UNII: 6DC9Q167V3)
Sodium Lauryl Sulfate(UNII: 368GB5141J)
Poloxamer 407(UNII: TUF2IVW3M2)
Sodium Benzoate(UNII: OJ245FE5EU)
Phosphoric Acid(UNII: E4GA8884NN)
Eucalyptol(UNII: RV6J6604TK)
Thymol(UNII: 3J50XA376E)
Methyl Salicylate(UNII: LAV5U5022Y)
Saccharin Sodium(UNII: SB8ZUX40TY)
Menthol, Unspecified Form(UNII: L7T10EIP3A)
Sodium Phosphate, Dibasic, Anhydrous(UNII: 22ADO53M6F)
Sucralose(UNII: 96K6UQ3ZD4)
FD&C Red No. 40(UNII: WZB9127XOA)
FD&C Blue No. 1(UNII: H3R47K3TBD)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42002-507-9627 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/07/2012
2NDC:42002-507-9595 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/07/2012
3NDC:42002-507-73250 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/07/2012
4NDC:42002-507-72500 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/07/2012
5NDC:42002-507-711000 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product25/07/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 07/25/2012 10/01/2018

PRINCIPAL DISPLAY PANEL

LISTERINE®
TOTAL CARE
ZERO
ANTICAVITY MOUTHWASH

SODIUM FLUORIDE & ACIDULATED PHOSPHATE TOPICAL SOLUTION
6
BENEFITS
IN 1

  • Helps Prevent Cavities
  • Restores Enamel
  • Strengthens Teeth
  • Kills Bad Breath Germs
  • Cleans the Whole Mouth
  • Freshens Breath

FRESH MINT

500 mL (1.05 Pt)

IMPORTANT: Read directions
for proper use.

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label