COLGATE OPTIC WHITE STAIN FIGHTER CLEAN 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® Clean 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, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Sodium Saccharin, Benzyl Alcohol, Titanium Dioxide.

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®

REMOVES 5X MORE SUFACE 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 CLEAN MINT 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-261
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) 191.18 mg  in 1 g
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)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-261-711 in 1 CARTON06/01/2022
1119 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-261-021 in 1 CARTON06/01/2022
256.6 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-261-601 in 1 CARTON06/01/2022
3170 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:35000-261-331 in 1 CARTON06/01/2022
436.8 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:35000-261-301 in 1 CARTON06/01/2022
585 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/01/2022
Labeler - Colgate-Palmolive Company (001344381)

Revised: 6/2022
Document Id: 675b5ec7-6e88-4607-8b39-86c498dc34a4
Set id: 518edd7f-7046-4432-9997-a677f90abc24
Version: 1
Effective Time: 20220606
 
Colgate-Palmolive Company