COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH- cetylpyridinium chloride rinse

Colgate Total Advanced Gum Health Mouthwash by

Drug Labeling and Warnings

Colgate Total Advanced Gum Health Mouthwash 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, citric acid, sodium saccharin, sucralose, FD&C green no. 3

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®

GUM HEALTH

Advanced Gum Protection for
45% Stronger, Healthier Gums*

1. Fights plaque between teeth & along
   the gum line
2. Kills 99% of germs on contact
3. 12-hour protection against bacteria
   that cause gingivitis

CLEAN MINT

16.9 FL OZ
(1.05 PT)
500 mL

P9903746

INGREDIENTS AND APPEARANCE

COLGATE TOTAL ADVANCED GUM HEALTH MOUTHWASH 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67659-502(NDC:35000-723)
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.75 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
POLOXAMER 407 (UNII: TUF2IVW3M2)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

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: 67659-502-30	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	03/01/2015

Labeler - Team Technologies, Inc (192339703)

Registrant - Team Technologies, Inc (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
Team Technologies, Inc		079337800	repack(67659-502) , relabel(67659-502)