CREST PRO-HEALTH GUM RESTORE SMOOTH MINT- cetylpyridinium chloride rinse

Drug Labeling and Warnings

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 ifsymptoms 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, sodium benzoate, zinc lactate,
sodium saccharin, sucralose, benzoic acid, red 33, green 3

Questions?

1-800-285-9139

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

ALCOHOL FREE

Crest

PRO-HEALTH

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

GUM

RESTORE

24 HR

PROTECTION

WITH ADVANCED

COOLING TECHNOLOGY

Helps Reduce

Gum Inflammation

SMOOTH MINT

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

CREST PRO-HEALTH  GUM RESTORE SMOOTH MINT
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84126-649
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ZINC LACTATE (UNII: 2GXR25858Y)
RED 33 (UNII: 9DBA0SBB0L)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
GREEN 3 (UNII: 3P3ONR6O1S)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Product Characteristics
Color	purple	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84126-649-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/01/2026

Labeler - The Procter & Gamble Manufacturing Company (004238200)