COLGATE TOTAL WHITENING- sodium fluoride and triclosan gel, dentifrice
Mission Hills, S.A. de C.V.

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Colgate®
Total®
Whitening Gel

Drug Facts

Active ingredients	Purpose
Sodium fluoride 0.24% (0.14% w/v fluoride ion)	Anticavity
Triclosan 0.30%	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, cellulose gum, flavor, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, mica, titanium dioxide, FD&C blue no.1

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 221 g Tube Carton

Helps Prevent Cavities • Gingivitis • Plaque

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®
Whitening
Gel

ADA
Accepted
American
Dental
Association ®

NET WT 7.8 OZ (221 g)

Fights Tartar Buildup • Whitens Teeth

PRINCIPAL DISPLAY PANEL - 221 g Tube Carton

COLGATE TOTAL WHITENING
sodium fluoride and triclosan gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-002
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	2.4 mg in 1 g
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
hydrated silica (UNII: Y6O7T4G8P9)
glycerin (UNII: PDC6A3C0OX)
sorbitol (UNII: 506T60A25R)
sodium lauryl sulfate (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
sodium hydroxide (UNII: 55X04QC32I)
propylene glycol (UNII: 6DC9Q167V3)
carrageenan (UNII: 5C69YCD2YJ)
saccharin sodium (UNII: SB8ZUX40TY)
mica (UNII: V8A1AW0880)
titanium dioxide (UNII: 15FIX9V2JP)
FD&C blue no. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	WHITE, BLUE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65954-002-78	1 in 1 CARTON	10/01/2009	10/01/2021
1		221 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020231	10/01/2009	10/01/2021

Labeler - Mission Hills, S.A. de C.V. (812312122)

Revised: 1/2022

Document Id: 8764f5b8-d9b4-4bc2-9973-b8fd16928b56

Set id: 6d23bd9d-7cde-4426-ba24-993a91ace9d0

Version: 2

Effective Time: 20220114

Mission Hills, S.A. de C.V.

Colgate® Total® Whitening Gel