Colgate® Optic White® Stain Fighter® With Baking Soda

Colgate Optic White Stain Fighter by

Drug Labeling and Warnings

Colgate Optic White Stain Fighter by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Mission Hills, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE OPTIC WHITE STAIN FIGHTER WITH BAKING SODA- sodium fluoride paste, dentifrice 
Colgate-Palmolive Company

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Colgate® Optic White® Stain Fighter®
With Baking Soda

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (0.15% 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 2ask a dentist or physician

Inactive ingredients

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Sodium Saccharin, Benzyl Alcohol, Sodium Bicarbonate.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®
STAIN FIGHTER®
WITH BAKING SODA

REMOVES 5X MORE SURFACE STAINS*
WITH MICRO-POLISHING ACTION

ENAMEL SAFE
NET WT 6.0 OZ (170 g)

CLEAN MINT PASTE

Principal Display Panel - 170 g Tube Carton
COLGATE OPTIC WHITE STAIN FIGHTER  WITH BAKING SODA
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-264
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35000-264-601 in 1 CARTON06/02/202212/31/2024
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 35000-264-421 in 1 CARTON06/02/202212/31/2024
2119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02106/02/202212/31/2024
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Mission Hills, S.A. de C.V.812312122ANALYSIS(35000-264) , MANUFACTURE(35000-264) , PACK(35000-264) , LABEL(35000-264)

Revised: 12/2019
Document Id: f4d066b4-3743-443a-8e01-9671691b7386
Set id: 14c8cb31-3521-4447-9781-efa3d9c4ab8e
Version: 2
Effective Time: 20191219