COLGATE TOTAL ADVANCE WHITENING- sodium fluoride and triclosan paste, dentifrice

Colgate by

Drug Labeling and Warnings

Colgate by is a Otc medication manufactured, distributed, or labeled by Team Technologies, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Triclosan 0.30%

Purpose

Anticavity

Antigingivitis

Uses

aids in the prevention of:

• cavities
• plaque
• gingivitis

Warnings

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Ask a dentist before use if you have

• bleeding or redness lasting more than 2 weeks
• pain, swelling, pus, loose teeth, or more spacing between teeth

These may be signs of periodontitis, a serious form of gum disease.

Directions

supervise children as necessary until capable of using without supervision.

• adults and children 6 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
• children under 12 years: instruct in good brushing and rinsing habits ; (to minimize swallowing)
• children under 6 years: do not use unless directed by a dentist or a physician

Antiplaque and antigingivitis use not proven in children.

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, titanium dioxide

Questions or comments?

Call toll-free 1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022  Made in U.S.A.
www.colgatetotal.com

PRINCIPAL DISPLAY PANEL - 226 g Tube

Helps Prevent Cavities Gingivitis Plaque

Colgate ®
Total ®
Anticavity Fluoride and Antigingivitis Toothpaste

ADVANCED WHITENING
PASTE

HELPS
REMOVE &
PREVENT
STAINS*

ADA
ACCEPTED
American
Dental
Association ®

NET WT 8.0 OZ (226 g)

PRINCIPAL DISPLAY PANEL - 226 g carton

Helps Prevent Cavities Gingivitis Plaque

Colgate ®
Total®
Anticavity Fluoride and Antigingivitis Toothpaste

ADVANCED WHITENING
PASTE

HELPS
REMOVE &
PREVENT
STAINS*

ADA
ACCEPTED
American
Dental
Association ®

NET WT 8.0 OZ (226 g)

INGREDIENTS AND APPEARANCE

COLGATE  TOTAL ADVANCE WHITENING
sodium fluoride and triclosan paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67659-350(NDC:35000-364)
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.5 mg  in 1 g
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARRAGEENAN (UNII: 5C69YCD2YJ)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67659-350-06	226 g in 1 TUBE; Type 1: Convenience Kit of Co-Package	05/20/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020231	08/09/2008

Labeler - Team Technologies, Inc (192339703)

Registrant - Team Technologies, Inc (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
Team Technologies, Inc		079337800	repack(67659-350) , relabel(67659-350)