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

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COLGATE® Great Regular Flavor Fluoride Toothpaste

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 the 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 or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

Colgate®
Anticavity
Fluoride Toothpaste

ADA
Accepted
American
Dental
Association ®

NET WT 4.0 OZ (113 g)

Cavity
Protection

Strengthens Teeth
with Active Fluoride

Great Regular Flavor

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
COLGATE GREAT REGULAR FLAVOR 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-913
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
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 49.14 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
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:35000-913-2024 g in 1 TUBE; Type 0: Not a Combination Product11/05/2005
2NDC:35000-913-331 in 1 CARTON11/05/200512/31/2007
236.8 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-913-691 in 1 CARTON11/05/2005
3113 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:35000-913-461 in 1 CARTON11/05/200501/31/2007
4130 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:35000-913-60170 g in 1 TUBE; Type 0: Not a Combination Product11/05/2005
6NDC:35000-913-641 in 1 CARTON11/05/200501/31/2007
6181 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:35000-913-821 in 1 CARTON11/05/200501/31/2007
7232 g in 1 TUBE; Type 0: Not a Combination Product
8NDC:35000-913-044.25 g in 1 POUCH; Type 0: Not a Combination Product11/05/2005
9NDC:35000-913-791 in 1 CARTON11/05/200501/31/2007
979 g in 1 TUBE; Type 0: Not a Combination Product
10NDC:35000-913-9399 g in 1 TUBE; Type 0: Not a Combination Product11/05/200501/31/2007
11NDC:35000-913-481 in 1 CARTON11/05/2005
11226 g in 1 TUBE; Type 0: Not a Combination Product
12NDC:35000-913-011 in 1 CARTON11/05/2005
1228 g in 1 TUBE; Type 0: Not a Combination Product
13NDC:35000-913-581 in 1 CARTON11/05/2005
1370 g in 1 TUBE; Type 0: Not a Combination Product
14NDC:35000-913-921 in 1 CARTON11/05/2005
14141 g in 1 TUBE; Type 0: Not a Combination Product
15NDC:35000-913-303 in 1 CARTON11/05/2005
15170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02111/05/2005
Labeler - Colgate-Palmolive Company (001344381)
Registrant - Colgate-Palmolive Company (001344381)

Revised: 12/2019
Document Id: 47460974-c56a-4db6-9ebb-5fbdecbbb067
Set id: 730f40f6-6ac6-49bd-888b-c0b5818a03c8
Version: 3
Effective Time: 20191203
 
Colgate-Palmolive Company