COLGATE GREAT REGULAR FLAVOR- sodium monofluorophosphate paste, dentifrice 
Colgate-Palmolive Company

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COLGATE® Great Regular Flavor

Drug Facts

Active ingredient

Sodium Monofluorophosphate 0.76% (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

Dicalcium Phosphate Dihydrate, Water, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Tetrasodium Pyrophosphate, Sodium Saccharin.

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

Cavity
Protection

NET WT 6.0 OZ (170 g)

ADA
Accepted
American
Dental
Association ®

Strengthens Teeth
with Active Fluoride

Great Regular Flavor

Principal Display Panel - 170 g Tube Carton
COLGATE GREAT REGULAR FLAVOR 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-257
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-257-011 in 1 CARTON06/18/202212/31/2024
1113 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-257-091 in 1 CARTON06/18/202212/31/2024
2170 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-257-051 in 1 CARTON06/18/202212/31/2024
3141 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02106/18/202212/31/2024
Labeler - Colgate-Palmolive Company (001344381)

Revised: 9/2024
Document Id: 1e12437f-2ee6-4cf2-874a-f9ad672729f8
Set id: c46add36-1411-589c-187e-efc3932073cb
Version: 2
Effective Time: 20240927
 
Colgate-Palmolive Company