COLGATE OPTIC WHITE ENAMEL WHITE- sodium monofluorophosphate paste, dentifrice
Mission Hills S.A de C.V

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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Drug Facts

Active ingredient

Sodium monofluorophosphate 1.14% (0.22% 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

calcium pyrophosphate, propylene glycol, PEG/PPG 116/66 copolymer, PEG-12, glycerin, PVP, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, silica, hydrogen peroxide, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

Colgate®

SAME WHITENING INGREDIENT AS STRIPS*
WHITER TEETH IN 1 WEEK

FLUORIDE TOOTHPASTE | *CONTAINS A LOWER LEVEL OF HYDROGEN PEROXIDE VS. STRIPS

NET WT 4.0 OZ (113 g)

NEW

OPTIC
WHITE™

ENAMEL WHITE

FORTIFIES ENAMEL FOR A STRONG WHITE

LUMINOUS MINT

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

COLGATE OPTIC WHITE ENAMEL WHITE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-561
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION)	SODIUM MONOFLUOROPHOSPHATE	11.4 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PYROPHOSPHATE	351.1 mg in 1 g
PROPYLENE GLYCOL
POLYETHYLENE GLYCOL 600
GLYCERIN
POVIDONE K15
SODIUM LAURYL SULFATE
SODIUM PYROPHOSPHATE
SILICON DIOXIDE
HYDROGEN PEROXIDE
SACCHARIN SODIUM DIHYDRATE
PHOSPHORIC ACID
SUCRALOSE
BUTYLATED HYDROXYTOLUENE
WATER

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

Packaging
#	Item Code	Package Description
1	NDC:65954-561-69	1 in 1 CARTON
1		113 g in 1 TUBE
2	NDC:65954-561-26	1 in 1 CARTON
2		156 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	06/25/2012

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

Revised: 07/2012

Document Id: 9169dbde-a028-41b9-95e5-e91d7503a317

Set id: e1eaf027-9ca8-4530-b80d-db173b12ed50

Version: 1

Effective Time: 20120703

Mission Hills S.A de C.V