COLGATE OPTIC WHITE PROSERIES ENAMEL STRENGHT- 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® ProSeries Enamel Strength

Active ingredient

Sodium Monofluorophosphate 1.14% (0.19% 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

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

ENAMEL STRENGTH

NET WT 2.1 OZ (59 g)

PRINCIPAL DISPLAY PANEL - 59 g Tube Label
COLGATE OPTIC WHITE PROSERIES ENAMEL STRENGHT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-748
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLOXAMER 105 (UNII: XPP85ZHV76) 446 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:35000-748-301 in 1 CARTON11/25/2021
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-748-211 in 1 CARTON11/25/2021
259 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(35000-748) , MANUFACTURE(35000-748) , PACK(35000-748) , LABEL(35000-748)

Revised: 10/2019
Document Id: bdf4041c-e2b6-4c6a-b08c-a02353fd6b66
Set id: 75e1bd3b-a981-4cc3-ac92-b2e1383f0650
Version: 2
Effective Time: 20191031
 
Colgate-Palmolive Company