LISTERINE TOTAL CARE FRESH MINT ANTICAVITY- sodium fluoride mouthwash

Listerine Total Care Fresh Mint by

Drug Labeling and Warnings

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

Drug Details [pdf]

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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)

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Dist: Johnson & Johnson Healthcare Products
Division of McNEIL-PPC, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ANTICAVITY FLOURIDE MOUTHWASH

LISTERINE®

TOTAL CARE

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

SODIUM FLUORIDE &

ACIDULATED PHOSPHATE TOPICAL SOLUTION

6 IN 1

BENEFITS

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

500 mL (16.9 Fl Oz) FRESH MINT

INGREDIENTS AND APPEARANCE

LISTERINE TOTAL CARE FRESH MINT   ANTICAVITY
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0178
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: 69968-0178-3	95 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2009
2	NDC: 69968-0178-1	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2009
3	NDC: 69968-0178-2	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2009
4	NDC: 69968-0178-4	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	11/01/2009

Labeler - Johnson & Johnson Consumer Inc. (002347102)