Listerine Fluoride Defense description, usages, side effects, indications, overdosage, supplying and lots more!

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Listerine Fluoride Defense

Johnson & Johnson Healthcare Products, Division of McNEIL-PPC, Inc.

LISTERINE® Fluoride Defense Anticavity Mouthwash


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Listerine Fluoride Defense 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)

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®

Listerine Fluoride Defense

Listerine Fluoride Defense

Sodium Fluoride MOUTHWASH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42002-450
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.02 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
ALCOHOL
POLOXAMER 407
SODIUM LAURYL SULFATE
EUCALYPTOL
methyl salicylate
THYMOL
phosphoric acid
Sucralose
MENTHOL
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
FD&C BLUE NO. 1

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42002-450-71 1000 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2012-08-16


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