COLGATE ULTRABRITE ADVANCED WHITENING ANTICAVITY FLUORIDE CLEAN MINT- sodium fluoride paste, dentifrice
Colgate-Palmolive

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colgate UltraBrite® Advanced Whitening Anticavity Fluoride Toothpaste Clean Mint

Drug Facts

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, cocomidopropyl betaine, sodium saccharin, titanium dioxide

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

CLEAN MINT

Ultrabrite®
ANTICAVITY FLUORIDE TOOTHPASTE

NET WT 6.0 OZ (170 g)

WHITENS TEETH

Advanced
Whitening
All in One Toothpaste®

VALUE
30%
MORE
VS. 4.6 OZ SIZE

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

COLGATE ULTRABRITE ADVANCED WHITENING ANTICAVITY FLUORIDE CLEAN MINT
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35000-064
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
Sodium Lauryl Sulfate (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
Water (UNII: 059QF0KO0R)
Polyethylene Glycol 600 (UNII: NL4J9F21N9)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Saccharin Sodium (UNII: SB8ZUX40TY)
Sorbitol (UNII: 506T60A25R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Sodium Pyrophosphate (UNII: O352864B8Z)
Titanium dioxide (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35000-064-60	1 in 1 CARTON	08/23/2012	06/18/2014
1		170 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
OTC MONOGRAPH FINAL	part355	08/23/2012	06/18/2014

Labeler - Colgate-Palmolive (068693167)

Revised: 1/2018

Document Id: 862b8263-e5ae-4283-a3b5-e09f3df77947

Set id: d780b05b-cff1-46b8-9b59-884afd6e393d

Version: 2

Effective Time: 20180117

Colgate-Palmolive