COLGATE- sodium fluoride and triclosan paste, dentifrice

Colgate by

Drug Labeling and Warnings

Colgate by is a Otc medication manufactured, distributed, or labeled by Mission Hills, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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, 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 Mexico

www.colgatetotal.com

PRINCIPAL DISPLAY PANEL - 221 g Tube Carton

Helps Prevent Cavities Gingivitis Plaque

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

Whitening Paste

ADA
Accepted
American
Dental
Association ®

NET WT 7.8 OZ (221 g)

Fights Tartar Buildup Whitens Teeth

INGREDIENTS AND APPEARANCE

COLGATE   TOTAL WHITENING
sodium fluoride and triclosan paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-003
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
hydrated silica (UNII: Y6O7T4G8P9)
glycerin (UNII: PDC6A3C0OX)
sorbitol (UNII: 506T60A25R)
sodium lauryl sulfate (UNII: 368GB5141J)
carboxymethylcellulose sodium (UNII: K679OBS311)
sodium hydroxide (UNII: 55X04QC32I)
propylene glycol (UNII: 6DC9Q167V3)
carrageenan (UNII: 5C69YCD2YJ)
saccharin sodium (UNII: SB8ZUX40TY)
titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-003-78	1 in 1 CARTON
1		221 g in 1 TUBE

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

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