COLGATE OPTIC WHITE PLATINUM  COOL MINT- 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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Colgate® Optic White® Platinum Anticavity Fluoride Toothpaste Cool Mint

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% 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

Inactive ingredients

propylene glycol, calcium pyrophosphate, glycerin, PEG/PPG-116/66 copolymer, PEG-12, PVP, silica, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, disodium pyrophosphate, hydrogen peroxide, sodium saccharin, sucralose, BHT

Questions?

1-800-468-6502
www.colgateopticwhite.com

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

PRINCIPAL DISPLAY PANEL - 96 g Tube Label

Colgate®

OPTIC
WHITE
®
PLATINUM

WHITEN
& PROTECT

WHITESEALTECHNOLOGY

ANTICAVITY
FLUORIDE TOOTHPASTE

ENAMEL SAFE

COOL MINT

NET WT 3.4 OZ (96 g)

PRINCIPAL DISPLAY PANEL - 96 g Tube Label
COLGATE OPTIC WHITE PLATINUM   COOL MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-588
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 338.1 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POVIDONE K15 (UNII: E54VE15114)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-588-931 in 1 CARTON
196 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/18/2013
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 10/2013
Document Id: bde04a53-8166-48f2-8b97-ff1cdf3f6f1f
Set id: 3efc2f6c-7fd2-4c60-a5c5-40240fb71905
Version: 1
Effective Time: 20131014
 
Mission Hills S.A de C.V