LISTERINE SMART RINSE ANTICAVITY RINSE - FROZEN BUBBLE BLAST- sodium fluoride mouthwash

Listerine Smart Rinse Anticavity Rinse - Frozen by

Drug Labeling and Warnings

Listerine Smart Rinse Anticavity Rinse - Frozen 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 6 years of age and older:
  • use twice daily after brushing your teeth with a toothpaste
  • remove cap and hold bottle upright. Fill to 10 mL line by squeezing the front and back (not the sides) of the bottle. Pour in a cup.
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • replace cap promptly after use
  • 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 room temperature
• do not use if printed band around cap is broken or missing

Inactive ingredients

water, sorbitol, flavor, phosphoric acid, sucralose, cetylpyridinium chloride, disodium phosphate, sodium saccharin, menthol, blue 1, green 3

Questions?

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

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Distributed by:
JOHNSON & JOHNSON CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

LISTERINE®

SMART RINSE®

ANTICAVITY
FLUORIDE RINSE

Disney
FROZEN
As seen in
FROZEN
FEVER

Helps Prevent Cavities

Removes Particles
Brushing May Miss

BUBBLE BLAST

IMPORTANT: Read
directions for proper use.

ADA
ACCEPTED
American
Dental
Association®

BUBBLE
BLAST®

500 mL (16.9 fl oz)

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label - INCREDIBLES 2

LISTERINE®

SMART RINSE®

ANTICAVITY
FLUORIDE RINSE

Disney PIXAR
INCREDIBLES 2

Helps Prevent Cavities

Removes Particles
Brushing May Miss

BUBBLE BLAST

IMPORTANT: Read
directions for proper use.

ADA
ACCEPTED
American
Dental
Association®

BUBBLE
BLAST®

500 mL (16.9 fl oz)

INGREDIENTS AND APPEARANCE

LISTERINE SMART RINSE ANTICAVITY RINSE - FROZEN   BUBBLE BLAST
sodium fluoride mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0276
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)
phosphoric acid (UNII: E4GA8884NN)
sucralose (UNII: 96K6UQ3ZD4)
sodium phosphate, dibasic, anhydrous (UNII: 22ADO53M6F)
saccharin sodium (UNII: SB8ZUX40TY)
fd&c blue no. 1 (UNII: H3R47K3TBD)
fd&c green no. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0276-5	500 mL in 1 BOTTLE; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug	01/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/01/2011

Labeler - Johnson & Johnson Consumer Inc. (002347102)