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Colgate Optic White Enamel White

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 1.5mg in 1g
Labeler: Mission Hills S.A de C.V
NDC Code: 65954-561

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.

Colgate® Optic White Enamel White Fluoride Toothpaste 4.0OZ

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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask 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®

WHITER TEETH IN 1 WEEK
GOES BEYOND SURFACE STAIN REMOVAL TO DEEPLY WHITEN

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

OPTIC
WHITE
®

ENAMEL WHITE

FORTIFIES ENAMEL FOR A STRONG WHITE

NET WT 4.0 OZ (113 g)

LUMINOUS MINT

COLGATE OPTIC WHITE   ENAMEL WHITE
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-561
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM PYROPHOSPHATE351.1 mg  in 1 g
PROPYLENE GLYCOL 
PEG/PPG-116/66 COPOLYMER 
POLYETHYLENE GLYCOL 600 
GLYCERIN 
POVIDONE K15 
SODIUM LAURYL SULFATE 
SODIUM PYROPHOSPHATE 
SILICON DIOXIDE 
HYDROGEN PEROXIDE 
SACCHARIN SODIUM 
PHOSPHORIC ACID 
SUCRALOSE 
BUTYLATED HYDROXYTOLUENE 
WATER 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-561-691 TUBE in 1 CARTON
1113 g in 1 TUBE
2NDC:65954-561-261 TUBE in 1 CARTON
2156 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/25/2012
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 10/2013
 
Mission Hills S.A de C.V

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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