LISTERINE FLUORIDE DEFENSE ANTICAVITY MINT SHIELD- sodium fluoride mouthwash

Listerine Fluoride Defense Anticavity mint Shield by

Drug Labeling and Warnings

Listerine Fluoride Defense Anticavity mint Shield 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 12 years of age and older:
  • use twice daily after brushing your teeth with a toothpaste
  • vigorously swish 10 ml (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 12 years of age: consult a dentist or doctor

Other information

• store at controlled room temperature 20° - 25°C (68° - 77°F)
• cold weather may temporarily cloud this product

Inactive ingredients

water, sorbitol solution, alcohol (21.6%), poloxamer 407, sodium lauryl sulfate, eucalyptol, flavor, methyl salicylate, thymol, phosphoric acid, sucralose, menthol, disodium phosphate, FD&C blue no. 1

Questions?

Call toll-free 1-888-222-0182 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 1.0 L Bottle Label

LISTERINE®
FLUORIDE
DEFENSE™
ANTICAVITY MOUTHWASH

SODIUM FLUORIDE & ACIDULATD PHOSPHATE TOPICAL SOLUTION
Shields Teeth from
Cavity Causing Acids,
Rebuilds Minerals &
Strengthens Enamel

IMPORTANT: Read directions
for proper use.
Replaces LISTERINE® Restoring

FROM THE #1 DENTIST RECOMMENDED BRAND*
#1

MINT SHIELD®

INGREDIENTS AND APPEARANCE

LISTERINE FLUORIDE DEFENSE ANTICAVITY MINT SHIELD 
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42002-450
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)
Alcohol (UNII: 3K9958V90M)
Poloxamer 407 (UNII: TUF2IVW3M2)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Eucalyptol (UNII: RV6J6604TK)
Methyl Salicylate (UNII: LAV5U5022Y)
Thymol (UNII: 3J50XA376E)
Phosphoric Acid (UNII: E4GA8884NN)
Sucralose (UNII: 96K6UQ3ZD4)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42002-450-71	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	12/01/2011

Labeler - Johnson & Johnson Consumer Inc. (002347102)