COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN- 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® Advanced Vibrant Clean Toothpaste

Drug Facts

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

adults and children 6 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 6 to 12 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 6 yearsdo not use unless directed by a dentist or physician

Inactive ingredients

Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, PEG-12, Glycerin, Flavor, Hydrogen Peroxide, Sodium Lauryl Sulfate, Silica, 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 - 127 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

NOW 2X WHITENING INGREDIENT

OPTIC
WHITE®
ADVANCED

DEEPLY WHITENS FOR
UP TO FOUR SHADES*

HYDROGEN
2%
PEROXIDE

ENAMEL SAFE

NET WT 4.5 OZ (127 g)

VIBRANT CLEAN

PRINCIPAL DISPLAY PANEL - 127 g Tube Carton
COLGATE OPTIC WHITE ADVANCED VIBRANT CLEAN 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-979
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 398 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
POVIDONE K15 (UNII: E54VE15114)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
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:35000-979-321 in 1 CARTON10/14/2019
1127 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-979-861 in 1 CARTON10/14/2019
290 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-979-762 in 1 CARTON10/14/2019
390 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/14/2019
Labeler - Colgate-Palmolive Company (001344381)

Revised: 10/2019
Document Id: 4d04c04b-898f-4f97-9533-a8cf8c9089cf
Set id: ed20cf9d-6162-4337-bb0b-1a6a6e9e1dc3
Version: 1
Effective Time: 20191010
 
Colgate-Palmolive Company