COLGATE® OPTIC WHITE® CHARCOAL

COLGATE OPTIC WHITE CHARCOAL by

Drug Labeling and Warnings

COLGATE OPTIC WHITE CHARCOAL 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 CHARCOAL- sodium fluoride paste, dentifrice 
Colgate-Palmolive Company

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COLGATE® OPTIC WHITE® CHARCOAL

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, Charcoal Powder, Blue 1, Red 40, Titanium Dioxide.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®
WITH CHARCOAL

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

COOL MINT PASTE

ENAMEL SAFE

NET WT 4.2 OZ (119 g)

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
COLGATE OPTIC WHITE CHARCOAL 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-262
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)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35000-262-711 in 1 CARTON06/01/202212/31/2024
1119 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 35000-262-021 in 1 CARTON06/01/202212/31/2024
256.6 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 35000-262-601 in 1 CARTON06/01/202212/31/2024
3170 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 35000-262-331 in 1 CARTON06/01/202212/31/2024
436.8 g in 1 TUBE; Type 0: Not a Combination Product
5NDC: 35000-262-301 in 1 CARTON06/01/202212/31/2024
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 DRUGM02106/01/202212/31/2024
Labeler - Colgate-Palmolive Company (001344381)
Registrant - Mission Hills, S.A. de C.V. (812312122)
Establishment
NameAddressID/FEIBusiness Operations
Mission Hills, S.A. de C.V.812312122ANALYSIS(35000-262) , MANUFACTURE(35000-262) , PACK(35000-262) , LABEL(35000-262)

Revised: 12/2019