COLGATE® Great Regular Flavor Fluoride Toothpaste

COLGATE Great Regular Flavor by

Drug Labeling and Warnings

COLGATE Great Regular Flavor by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE GREAT REGULAR FLAVOR - sodium monofluorophosphate paste, dentifrice 
Mission Hills S.A de C.V

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® 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: 65954-060
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.0 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 FORM (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: 65954-060-2024 g in 1 TUBE; Type 0: Not a Combination Product11/05/2005
2NDC: 65954-060-331 in 1 CARTON11/05/2005
236.8 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 65954-060-691 in 1 CARTON11/05/2005
3113 g in 1 TUBE; Type 0: Not a Combination Product
4NDC: 65954-060-461 in 1 CARTON11/05/2005
4130 g in 1 TUBE; Type 0: Not a Combination Product
5NDC: 65954-060-60170 g in 1 TUBE; Type 0: Not a Combination Product11/05/2005
6NDC: 65954-060-641 in 1 CARTON11/05/2005
6181 g in 1 TUBE; Type 0: Not a Combination Product
7NDC: 65954-060-821 in 1 CARTON11/05/2005
7232 g in 1 TUBE; Type 0: Not a Combination Product
8NDC: 65954-060-044.25 g in 1 POUCH; Type 0: Not a Combination Product11/05/2005
9NDC: 65954-060-791 in 1 CARTON11/05/2005
979 g in 1 TUBE; Type 0: Not a Combination Product
10NDC: 65954-060-9399 g in 1 TUBE; Type 0: Not a Combination Product11/05/2005
11NDC: 65954-060-481 in 1 CARTON11/05/2005
11226 g in 1 TUBE; Type 0: Not a Combination Product
12NDC: 65954-060-011 in 1 CARTON11/05/2005
1228 g in 1 TUBE; Type 0: Not a Combination Product
13NDC: 65954-060-581 in 1 CARTON11/05/2005
1370 g in 1 TUBE; Type 0: Not a Combination Product
14NDC: 65954-060-921 in 1 CARTON11/05/2005
14141 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/05/2005
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019
Document Id: fb61fcd5-756d-415c-b718-fa6c1a916179
Set id: 0ad8745e-f682-4729-8917-15cb590a1226
Version: 10
Effective Time: 20190403