COLGATE TRIPLE ACTION ORIGINAL MINT FLUORIDE- sodium fluoride paste, dentifrice

Colgate Triple Action Original Mint Fluoride by

Drug Labeling and Warnings

Colgate Triple Action Original Mint Fluoride by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Canada. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of 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.

Directions

• Adults and children 2 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 physician.
• Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
• Children under 2 years: Ask a dentist or physician.

Inactive ingredients

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

Questions or comments?

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
Made in Canada
www.colgate.com

PRINCIPAL DISPLAY PANEL - 130 g Tube

Colgate®
Fluoride Toothpaste

NET WT 4.6 OZ (130 g)

Triple
Action

Original Mint

Cavity Protection
1

Whiter Teeth
2

Fresh Breath
3

INGREDIENTS AND APPEARANCE

COLGATE TRIPLE ACTION ORIGINAL MINT FLUORIDE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51442-536
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

Inactive Ingredients
Ingredient Name	Strength
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Polyethylene Glycol (UNII: 3WJQ0SDW1A)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Carboxymethylcellulose Sodium (UNII: K679OBS311)
Sodium Pyrophosphate (UNII: O352864B8Z)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Saccharin Sodium (UNII: SB8ZUX40TY)
Titanium Dioxide (UNII: 15FIX9V2JP)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	BLUE, WHITE (Stripe) , GREEN (Stripe)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51442-536-46	1 in 1 CARTON
1		130 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	11/17/2010

Labeler - Colgate-Palmolive Canada (259157246)