CREST PRO-HEALTH INTENSE FRESH MINT- 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 0.05%

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, alcohol (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, yellow 6, green 3

Questions?

1–800–285–9139

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

COOLING

SENSATION

Crest®

PRO-HEALTH™

CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL MOUTHWASH

INTENSE

99% GERM KILL

FRESH MINT

• KEEPS TEETH CLEANER LONGER*
• FRESHENS BREATH
• FIGHTS PLAQUE & GINGIVITIS

See back for important

ingredient information.

500 mL

(16.9 FL OZ)

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  INTENSE FRESH MINT
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-480
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.05 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
ALCOHOL (UNII: 3K9958V90M)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-480-05	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2018
2	NDC: 37000-480-10	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/01/2018

Labeler - The Procter & Gamble Manufacturing Company (004238200)