Colgate® Optic White® Sparkling

Colgate Optic White Sparkling by

Drug Labeling and Warnings

Colgate Optic White Sparkling by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE OPTIC WHITE SPARKLING- sodium monofluorophosphate paste, dentifrice 
Colgate-Palmolive Company

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Colgate® Optic White® Sparkling

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, PEG/PPG-116/66 Copolymer, PEG-12, Glycerin, PVP, Silica, Flavor, Tetrasodium Pyrophosphate, Sodium Lauryl Sulfate, Hydrogen Peroxide, Disodium Pyrophosphate, Sodium Saccharin, Sucralose, BHT.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®

LOVERS

REMOVES STUBBORN,
DARK STAINS

DEEPLY WHITENS
BEYOND THE SURFACE

FRESH MINT

NET WT 4.6 OZ (130 g)
ENAMEL SAFE

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton
COLGATE OPTIC WHITE SPARKLING 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-758
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)  
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE K15 (UNII: E54VE15114)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
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: 35000-758-941 in 1 CARTON07/27/202212/31/2025
1130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02107/27/202212/31/2025
Labeler - Colgate-Palmolive Company (001344381)
Registrant - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Mission Hills S.A de C.V812312122MANUFACTURE(35000-758)

Revised: 10/2019