COLGATE OPTIC WHITE STAIN FIGHTER  WITH BAKING SODA- sodium fluoride 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® 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 2 yearsask a dentist or physician

Inactive ingredients

Water, Hydrated Silica, Sorbitol, Glycerin, PEG-12, Pentasodium Triphosphate, Tetrapotassium Pyrophosphate, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Xanthan Gum, Sodium Hydroxide, 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

ENAMEL SAFE
NET WT 6.0 OZ (170 g)

CLEAN MINT PASTE

NEW

OPTIC
WHITE®

STAIN FIGHTER®
WITH BAKING SODA

REMOVES 6X MORE SURFACE STAINS*
WITH MICRO-POLISHING ACTION

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:35000-809
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)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-809-601 in 1 CARTON11/15/2021
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-809-421 in 1 CARTON11/15/2021
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 FINALpart35511/15/2021
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Mission Hills, S.A. de C.V.812312122MANUFACTURE(35000-809) , ANALYSIS(35000-809) , PACK(35000-809) , LABEL(35000-809)

Revised: 11/2021
Document Id: 8c2ef2f8-0bd5-4b75-a09f-f4e7dd14e73a
Set id: 8e6113e2-101b-4bde-90e9-6ab32c6ebf5c
Version: 1
Effective Time: 20211116
 
Colgate-Palmolive Company