COLGATE TOTAL ADVANCED PRO-SHIELD SPEARMINT SURGE- cetylpyridinium chloride rinse

Colgate Total Advanced Pro-Shield Spearmint Surge by

Drug Labeling and Warnings

Colgate Total Advanced Pro-Shield Spearmint Surge by is a Otc medication manufactured, distributed, or labeled by Team Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Cetylpyridinium chloride 0.075%

Purpose

Antigingivitis/antiplaque

Uses

helps prevent and reduce plaque and gingivitis

Warnings

Ask a dentist if condition persists or 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

• adults and children 12 years of age and 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, propylene glycol, sorbitol, poloxamer 407, flavor, potassium sorbate, sodium saccharin, citric acid, sucralose, FD&C green no. 3, FD&C yellow no. 6

Other Information

• this rinse is not intended to replace brushing or flossing
• store at 59°F to 77°F
• keep from freezing

Questions?

1-800-468-6502

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Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ALCOHOL FREE

Colgate®

Antigingivitis/Antiplaque Mouthwash

Total®

ADVANCED
PRO-SHIELD ™

12-HR Protection Against Germs*

• KILLS 99% OF GERMS ON CONTACT
• SIGNIFICANTLY REDUCES PLAQUE
• HELPS PREVENT GINGIVITIS
• NO BURN OF ALCOHOL
• FRESHENS BREATH

SPEARMINT SURGE™

16.9 FL OZ
(1.05 PT)
500 mL

P9892865

INGREDIENTS AND APPEARANCE

COLGATE TOTAL ADVANCED PRO-SHIELD SPEARMINT SURGE 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67659-501(NDC: 35000-721)
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	15 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
LEVOMENTHOL (UNII: BZ1R15MTK7)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

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: 67659-501-30	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/06/2013

Labeler - Team Technologies, Inc (192339703)

Registrant - Team Technologies, Inc (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
Team Technologies, Inc		079337800	repack(67659-501) , relabel(67659-501)