CREST COMPLETE PLUS SCOPE INTENSE FRESHNESS- sodium fluoride rinse

Crest Complete Plus Scope by

Drug Labeling and Warnings

Crest Complete Plus Scope by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company, 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

Uses

Aids in the prevention of dental cavities

Warnings

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 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, alcohol (14.25 wt%), propylene glycol, flavor, benzoic acid, poloxamer
407, cetylpyridinium chloride, sucralose, phosphoric acid, disodium phosphate, yellow 5, blue 1

Questions?

1–800–285–9139

PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label

+FLUORIDE

Crest

complete

plus Scope

ANTICAVITY FLUORIDE

MOUTHWASH

ANTI-CAVITY

+

INTENSE FRESHNESS

IMPORTANT: Read

directions for proper use.

SEE BACK FOR

IMPORTANT

INGREDIENT

INFORMATION

FRESH MINT

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

CREST COMPLETE PLUS SCOPE  INTENSE FRESHNESS
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-709
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
PHOSPHORIC ACID (UNII: E4GA8884NN)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-709-33	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/14/2011
2	NDC: 69423-709-03	3 in 1 CELLO PACK	03/14/2011
2		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 Drug	M021	03/14/2011

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
SUNLIT FLUO & CHEMICAL CO., LTD. CHUNG-LI FACTORY		658870890	api manufacture(69423-709)