LISTERINE TOTAL CARE ZERO ALCOHOL ANTICAVITY FRESH MINT- sodium fluoride mouthwash

Listerine Total Care Zero Alcohol Anticavity by

Drug Labeling and Warnings

Listerine Total Care Zero Alcohol Anticavity by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 6 years of age and older:
  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • supervise children as necessary until capable of using without supervision
• Children under 6 years of age: consult a dentist or doctor

Other information

• store at room temperature
• cold weather may temporarily cloud this product

Inactive ingredients

water, sorbitol, propylene glycol, poloxamer 407, sodium lauryl sulfate, flavor, sodium benzoate, phosphoric acid, eucalyptol, methyl salicylate, thymol, sodium saccharin, menthol, disodium phosphate, sucralose, red 40, blue 1

Questions?

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

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®
TOTAL CARE
ZERO ALCOHOL
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.

INGREDIENTS AND APPEARANCE

LISTERINE TOTAL CARE ZERO ALCOHOL ANTICAVITY   FRESH MINT
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0194
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.1 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
1	NDC: 69968-0194-2	27 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2012
2	NDC: 69968-0194-9	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2012
3	NDC: 69968-0194-5	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2012
4	NDC: 69968-0194-1	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/25/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	07/25/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)