Crest ® PRO-HEALTH™ MULTI-PROTECTION Cool Wintergreen

Drug Labeling and Warnings

Drug Details [pdf]

CREST PRO-HEALTH- cetylpyridinium chloride rinse 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Crest ®

PRO-HEALTH™

MULTI-PROTECTION

Cool Wintergreen

Drug Facts

Active ingredient

Cetylpyridinium chloride 0.07%

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 6 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 6 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 years to under 12 years of age: supervise use
• children under 6 years of age: do not use

Inactive ingredients

water, glycerin, propylene glycol, flavor, poloxamer 407, methylparaben, propylparaben, sodium saccharin, yellow 6, green 3

Questions?

1–800–285–9139

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ALCOHOL FREE

Crest®
PRO-HEALTH™

CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL MOUTHWASH

99% GERM KILL

AND A HEALTHIER MOUTH*

MULTI-PROTECTION COOL WINTERGREEN

REDUCES PLAQUE BACTERIA

HELPS PREVENT GINGIVITIS

FRESHENS BREATH

1 L(33.8 FL OZ)

CREST PRO-HEALTH 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-584
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.014 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
METHYLPARABEN (UNII: A2I8C7HI9T)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-584-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/04/2007	08/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/04/2007	08/17/2019

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 6/2018

Document Id: 6e111971-e9a3-3ed4-e053-2991aa0a87dd

34390-5

Set id: 3d6ec358-352f-19d1-e054-00144ff88e88

Version: 2

Effective Time: 20180607

 

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