Listerine smart rinse barbie mouthwash

Spl unclassified section

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

Otc - keep out of reach of children section

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
    • remove cap and hold bottle upright. Fill to10 ml line by squeezing the front and back (not the sides) of the bottle. Stop squeezing. Excess liquid will drain back into the bottle. Pour out.
    • 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
    • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
    • 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 controlled room temperature 20 - 25C (68 - 77F)
  • do not use if printed band around cap is broken or missing

Inactive ingredients

water, sorbitol solution, flavor, phosphoric acid, sucralose, cetylpyridinium chloride, disodium phosphate, sodium saccharin, D&C red no. 33

Questions?

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

Ingredients and appearance - Product information

Listerine smart rinse barbie mouthwash- Sodium fluoride

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 42002-418
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 0.1 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Water ( UNII: 059QF0KO0R)
Sorbitol ( UNII: 506T60A25R)
Phosphoric acid ( UNII: E4GA8884NN)
Sucralose ( UNII: 96K6UQ3ZD4)
Cetylpyridinium chloride ( UNII: D9OM4SK49P)
Saccharin sodium ( UNII: SB8ZUX40TY)
D&c red no. 33 ( UNII: 9DBA0SBB0L)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part355 USA

Labeler - Johnson & Johnson Consumer Inc.( 002347102)

Principal display panel - 500 ml bottle label

LISTERINE ®
SMART RINSE ®
ANTICAVITY
FLUORIDE RINSE

Barbie

Helps Prevent Cavities
Removes Particles
Brushing May Miss

IMORTANT: Read
Directions for proper use.

ADA
Accepted

American
Dental
Association ®

Fab
Bubble Gum™

500 mL (16.9 fl oz)