CREST PRO-HEALTH MULTI-PROTECTION REFRESHING CLEAN MINT- cetylpyridinium chloride rinse

Crest Pro-Health Multi-Protection by

Drug Labeling and Warnings

Crest Pro-Health Multi-Protection 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 0.07%

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, flavor, poloxamer 407, methylparaben, sodium saccharin, propylparaben, blue 1

Questions?

1–800–285–9139

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati OH 45202

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

ALCOHOL FREE

Crest®
PRO-HEALTH®
CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

MULTI-PROTECTION

• KILLS GERMS
• HELPS PREVENT PLAQUE
• HELPS PREVENT GINGIVITIS
• KEEPS TEETH CLEANER LONGER †
• FRESHENS BREATH
• NO BURN OF ALCOHOL

REFRESHING
CLEAN MINT

1 L (33.8 FL OZ)

99289266

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH MULTI-PROTECTION  REFRESHING CLEAN MINT
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-451
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 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLOXAMER 407 (UNII: TUF2IVW3M2)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-451-01	36 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2011
2	NDC: 37000-451-03	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2011
3	NDC: 37000-451-04	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2011
4	NDC: 37000-451-05	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2011
5	NDC: 37000-451-06	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/03/2011
6	NDC: 37000-451-10	2 in 1 PACKAGE	02/03/2011
6		1000 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	02/03/2011

Labeler - The Procter & Gamble Manufacturing Company (004238200)