SCOPE GET FRESH CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH- cetylpyridinium chloride rinse

Scope by

Drug Labeling and Warnings

Scope by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company, THE PROCTER & GAMBLE MANUFACTURING COMPANY, Vertellus LLC, Merck KGaA, Dishman Pharmaceuticals and Chemicals Limited. 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

Warning

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

Keep out of reach of children 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

Questions?

1-800-285-9139

Inactive ingredients

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

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

Principal Display Panel 1L bottle

SpearMint

SO FRESH &

so clean™

Scope®

CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

GET FRESH™

plus extreme freshness

See back for important ingredient information

Kills 99%

of bad breath bacteria*

BOLD FRESHNESS you can feel

with alcohol

1 L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

SCOPE  GET FRESH CPC ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-858
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BENZOIC ACID (UNII: 8SKN0B0MIM)
WATER (UNII: 059QF0KO0R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ALCOHOL (UNII: 3K9958V90M)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-858-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/24/2022

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
THE PROCTER & GAMBLE MANUFACTURING COMPANY		005279245	manufacture(69423-858) , pack(69423-858)

Establishment
Name	Address	ID/FEI	Business Operations
Vertellus LLC		080497994	api manufacture(69423-858)

Establishment
Name	Address	ID/FEI	Business Operations
Merck KGaA		342249299	api manufacture(69423-858)

Establishment
Name	Address	ID/FEI	Business Operations
Dishman Pharmaceuticals and Chemicals Limited		918604427	api manufacture(69423-858)