CREST PRO-HEALTH ADVANCED W/EXTRA WHITENING- sodium fluoride rinse

Crest Pro-Health by

Drug Labeling and Warnings

Crest Pro-Health 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 0.02% (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 & older:
  • Use twice a day 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.
  • 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 12 years of age: consult a dentist or doctor.

Inactive ingredients

water, glycerin, hydrogen peroxide, poloxamer 407, flavor, polysorbate 80, sodium saccharin, sucralose, phosphoric acid, disodium phosphate

Questions?

1-800-285-9139

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

ALCOHOL FREE
WITH FLUORIDE

Crest®
PRO-HEALTH™
ADVANCED
ANTICAVITY FLUORIDE MOUTHWASH

STRONGER TEETH*
FOR A HEALTHIER MOUTH

WITH
EXTRA WHITENING

• KILLS BAD BREATH GERMS
• WHITER SMILE** IN 7 DAYS
• HELPS PREVENT CAVITIES
• STRENGTHENS ENAMEL
• FRESHENS BREATH

ENERGIZING MINT

IMPORTANT: Read directions for proper use.

946 mL
(32 FL OZ)

97275245

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  ADVANCED W/EXTRA WHITENING
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-867
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)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-867-01	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2015
2	NDC: 37000-867-02	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/20/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/20/2015

Labeler - The Procter & Gamble Manufacturing Company (004238200)