CREST PRO-HEALTH FOR ME ANTICAVITY FLUORIDE- sodium fluoride rinse

Crest Pro-Health For Me by

Drug Labeling and Warnings

Crest Pro-Health For Me by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Fluoride 0.022% (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 & older: Use twice a day after brushing your teeth with a toothpaste.
• To dispense 10 mL dose: Remove cap and squeeze the front and back of the bottle (not the sides) to fill the reservoir. Allow excess liquid to drain back into the bottle. Pour out the dose.
• Vigorously swish the 10 mL 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.

Inactive ingredients

water, glycerin, propylene glycol, poloxamer, polysorbate 80, phosphoric acid, sodium benzoate, potassium sorbate, flavor, sodium saccharin, disodium phosphate, green 3.

Questions?

1-800-285-9139

SPL UNCLASSIFIED SECTION

DISTR. BY
PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ALCOHOL FREE
BREEZY MINT

DiSNEY
MAGIC TIMER™

STAR
WARS ™

Crest®
PRO-HEALTH
FOR ME ™
ANTICAVITY FLUORIDE RINSE

IMPORTANT: READ DIRECTIONS FOR PROPER USE
FIGHTS CAVITIES

ADA
Accepted
American
Dental
Association ®

500 mL (16.9 FL OZ)

96987154

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH FOR ME  ANTICAVITY FLUORIDE
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-006
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)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color	turquoise	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-006-15	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/19/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/19/2015

Labeler - The Procter & Gamble Manufacturing Company (004238200)