COLGATE OPTIC WHITE PRO SERIES STAIN PREVENTION- 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® Pro Series Stain Prevention

Active ingredients

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

Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 59 g Tube Label

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®

PRO SERIES

REMOVES
15 YEARS
OF STAINS*

5%
HYDROGEN
PEROXIDE

STAIN PREVENTION

NET WT 2.1 OZ (59 g)

PRINCIPAL DISPLAY PANEL - 59 g Tube Label
COLGATE OPTIC WHITE PRO SERIES STAIN PREVENTION 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-747
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
POLOXAMER 105 (UNII: XPP85ZHV76) 450.3 mg  in 1 g
CROSPOVIDONE (UNII: 2S7830E561)  
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-747-301 in 1 CARTON11/25/2021
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-747-321 in 1 CARTON11/25/2021
293 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-747-211 in 1 CARTON11/25/2021
359 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:35000-747-161 in 1 CARTON11/25/2021
46 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/23/2021
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Mission Hills, S.A. de C.V.812312122ANALYSIS(35000-747) , MANUFACTURE(35000-747) , PACK(35000-747) , LABEL(35000-747)

Revised: 10/2019
Document Id: 0fba6852-08bf-434e-8e4f-a2ae15c4c6d8
Set id: e18060c0-7e03-444c-a5ac-b8ba25ce14ea
Version: 2
Effective Time: 20191031
 
Colgate-Palmolive Company