COLGATE OPTIC WHITE PLATINUM ANTICAVITY FLUORIDE- sodium monofluorophosphate paste, dentifrice 
Colgate-Palmolive Company

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

Drug Facts

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

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

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

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

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

Colgate®

OPTIC
WHITE
®
PLATINUM™
ANTICAVITY FLUORIDE TOOTHPASTE

LASTING
WHITE™

WHITENS AND SEALS
OUT EVEN TOUGH STAINS*

with WHITESEAL™ TECHNOLOGY

ENAMEL SAFE

COOL MINT

NET WT 3.4 OZ (96 g)

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton
COLGATE OPTIC WHITE PLATINUM ANTICAVITY FLUORIDE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-952
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 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:35000-952-931 in 1 CARTON07/01/2015
196 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-952-861 in 1 CARTON07/01/2015
2127 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35507/01/2015
Labeler - Colgate-Palmolive Company (001344381)

Revised: 12/2019
Document Id: d1e974e6-d299-4a05-bfea-c3d9dba8fe41
Set id: a71d468a-5535-4f3b-acd5-d580f3a21404
Version: 1
Effective Time: 20191212
 
Colgate-Palmolive Company