Listerine Whitening Restoring description, usages, side effects, indications, overdosage, supplying and lots more!

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Listerine Whitening Restoring

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

LISTERINE WHITENING®RESTORING Fluoride Rinse


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Sodium fluoride 0.0221% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs

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 Whitening Restoring Other information

  • store at controlled room temperature 20° - 25°C (68° - 77°F)

Inactive ingredients

water, alcohol (10.5%), sorbitol solution, hydrogen peroxide, PEG-40 hydrogenated castor oil, flavors, poloxamer 407, sodium saccharin, phosphoric acid, disodium phosphate, sucralose

Questions?

call 1-888-222-5545, weekdays

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

LISTERINE®
WHITENING
fluoride whitening rinse

RESTORING

  • Whitens Teeth Safely
  • Restores Enamel to
    Strengthen Teeth
  • Helps Prevent Tooth Decay
  • Kills Bad Breath Germs

CLEAN MINT

473 mL (16 Fl Oz)

IMPORTANT: READ DIRECTION FOR PROPER USE.
DO NOT USE IF PRINTED LISTERINE® BAND AROUND CAP IS BROKEN OR MISSING

Listerine Whitening Restoring

Listerine Whitening Restoring

Sodium Fluoride RINSE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42002-420
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 0.2 mg

Inactive Ingredients

Ingredient Name Strength
water
ALCOHOL
sorbitol
hydrogen peroxide
POLYOXYL 40 HYDROGENATED CASTOR OIL
POLOXAMER 407
SACCHARIN SODIUM DIHYDRATE
phosphoric acid
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
Sucralose

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42002-420-16 473 in 1 BOTTLE, PLASTIC
2 NDC:42002-420-32 946 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2012-05-01


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