COLGATE PROCLINICAL - SPARKLING MINT- sodium fluoride paste, dentifrice

COLGATE PROCLINICAL - Sparkling Mint by

Drug Labeling and Warnings

COLGATE PROCLINICAL - Sparkling Mint by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Canada. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

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

Purpose

Anticavity

Uses

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

water, hydrated silica, sorbitol, glycerin, PEG-12, pentasodium triphosphate, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, cellulose gum, polyethylene, cocoamidopropyl betaine, sodium hydroxide, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1

Questions or comments?

Call toll free 1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 113 g Carton

Colgate®
Anticavity Fluoride Whitening Toothpaste

Paste

PRO
CLINICAL™
white

WHITER TEETH IN JUST 1 TUBE

NET WT 4.0 OZ (113 g)

Clinically Proven WHITENING TECHNOLOGY.

INGREDIENTS AND APPEARANCE

COLGATE PROCLINICAL - SPARKLING MINT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51442-543
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
Water (UNII: 059QF0KO0R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Polyethylene Glycol 600 (UNII: NL4J9F21N9)
Sodium Tripolyphosphate (UNII: 5HK03SA80J)
Sodium Pyrophosphate (UNII: O352864B8Z)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Carboxymethylcellulose Sodium (UNII: K679OBS311)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Sodium Hydroxide (UNII: 55X04QC32I)
Saccharin Sodium (UNII: SB8ZUX40TY)
Xanthan Gum (UNII: TTV12P4NEE)
Titanium Dioxide (UNII: 15FIX9V2JP)
FD&C Blue No. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	WHITE (Blue Speckles)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51442-543-69	1 in 1 CARTON
1		113 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	11/10/2010

Labeler - Colgate-Palmolive Canada (259157246)