CREST PRO-HEALTH CLINICAL- cetylpyridinium chloride 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

Cetylpyridinium chloride 0.1%

Purpose

Antigingivitis/Antiplaque

Uses

• helps prevent and reduce plaque and gingivitis
• helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums

Warnings

Ask a dentist if symptoms persist or condition worsens after regular use.

Keep out of reach of children under 12 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use
• adults and children 12 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • supervise use in children
• children under 12 years of age: do not use

Inactive ingredients

water, glycerin, hydrogen peroxide, flavor, sucralose, poloxamer 407

Questions?

1–800–285–9139

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Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Crest®

PRO-HEALTH™

CPC ANTIGINGIVITIS/ANTIPLAQUE

ORAL RINSE

ALCOHOL FREE

CLINICAL

OUR MOST ADVANCED RINSE EVER

• Reduces plaque & even helps prevent plaque regrowth
• Helps prevent & even helps reverse gingivitis in 2 weeks
• Kills 99% of germs to improve breath

DEEP CLEAN MINT

473mL

(16 FL OZ)

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  CLINICAL
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-843
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.02 g  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-843-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2011	02/10/2017
2	NDC: 37000-843-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2011
3	NDC: 37000-843-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/20/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/20/2011

Labeler - The Procter & Gamble Manufacturing Company (004238200)