Colgate® Optic White® Stain Fighter ™ Fresh Mint

Colgate® Optic White® Stain Fighter ™ Fresh Mint

Drug Labeling and Warnings

Drug Details

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COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT- 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 ™ Fresh Mint

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, benzyl alcohol, sodium saccharin, xanthan gum, sodium hydroxide, mica, titanium dioxide, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

NEW
STAIN REMOVAL
TECHNOLOGY**

Colgate®

OPTIC
WHITE®

STAIN FIGHTER ™

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

NET WT 4.2 OZ (119 g)
ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE WHITENING

FRESH MINT GEL

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-936
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R) 191.17 mg  in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35000-936-711 in 1 CARTON11/30/2017
1119 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 35000-936-601 in 1 CARTON12/19/2018
2170 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 35000-936-021 in 1 CARTON03/12/2019
356.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/30/2017
Labeler - Colgate-Palmolive Company (001344381)

Revised: 12/2019
 
Colgate-Palmolive Company


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