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 Colgate-Palmolive Company, Colgate-Palmolive. 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: 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: 35000-364-16	1 in 1 CARTON	01/21/2010	01/01/2022
1		21 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-364-69	1 in 1 CARTON	10/04/2010	01/01/2022
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-364-66	1 in 1 CARTON	12/13/2010	01/01/2022
3		164 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-364-67	1 in 1 CARTON	07/22/2013	01/01/2022
4		215 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-364-48	1 in 1 CARTON	08/16/2012	01/01/2022
5		226 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 35000-364-87	2 in 1 CARTON	05/06/2011	01/01/2022
6		164 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-364)