SCOPE STAY STRONG- sodium fluoride 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, Merck KGaA, SUNLIT FLUO & CHEMICAL CO., LTD. CHUNG-LI FACTORY. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warning

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Adults and children 6 years & older: Use twice a day after brushing your teeth with a toothpaste.
• Vigorously swish the 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
• Do not swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
• Supervise children as necessary until capable of using without supervision.
• Children under 6 years of age: Consult a dentist or doctor.

Inactive ingredients

water, glycerin, propylene glycol, polysorbate 80, benzoic acid, flavor, saccharin, sodium benzoate, phosphoric acid, disodium phosphate, yellow 5, blue 1

Questions?

1-800-862-7442

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DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

Strong Mint

FLEX YOUR

freshness™

Scope®

ANTICAVITY FLUORIDE MOUTHWASH

STAY STRONG™

plus enamel protection

SEE BACK FOR IMPORTANT INGREDIENT INFORMATION

IMPORTANT: Read directions for proper use.

Kills 99%

of bad breath bacteria*

FORTIFIES ENAMEL with fluoride

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

SCOPE  STAY STRONG
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-859
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PHOSPHORIC ACID (UNII: E4GA8884NN)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
BASIC BLUE 1 (UNII: 92N74OA24D)
BASIC YELLOW 5 (UNII: 07BP340B4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
ALCOHOL (UNII: 3K9958V90M)
SUCRALOSE (UNII: 96K6UQ3ZD4)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-859-33	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	M021	01/24/2022

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
THE PROCTER & GAMBLE MANUFACTURING COMPANY		005279245	manufacture(69423-859) , pack(69423-859)

Establishment
Name	Address	ID/FEI	Business Operations
Merck KGaA		342249299	api manufacture(69423-859)

Establishment
Name	Address	ID/FEI	Business Operations
SUNLIT FLUO & CHEMICAL CO., LTD. CHUNG-LI FACTORY		658870890	api manufacture(69423-859)