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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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 older	brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 years	use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years	ask 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 - 232 g Tube Carton

Colgate®
Fluoride Toothpaste

ADA
ACCEPTED
American
Dental
Association ®

NET WT 8.2 OZ (232 g)

Cavity
Protection

Strengthens Teeth
with Active Fluoride

Great Regular Flavor

Principal Display Panel - 232 g Tube Carton

COLGATE GREAT REGULAR FLAVOR
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65954-060
Route of Administration	DENTAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION)	FLUORIDE ION	1.0 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM LAURYL SULFATE	49.14 mg in 1 g
WATER
GLYCERIN
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM PYROPHOSPHATE
SACCHARIN SODIUM

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:65954-060-20	24 g in 1 TUBE
2	NDC:65954-060-33	1 in 1 CARTON
2		36.8 g in 1 TUBE
3	NDC:65954-060-69	1 in 1 CARTON
3		113 g in 1 TUBE
4	NDC:65954-060-46	1 in 1 CARTON
4		130 g in 1 TUBE
5	NDC:65954-060-60	170 g in 1 TUBE
6	NDC:65954-060-64	1 in 1 CARTON
6		181 g in 1 TUBE
7	NDC:65954-060-82	1 in 1 CARTON
7		232 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	11/05/2005

Labeler - Mission Hills S.A de C.V (812312122)

Revised: 02/2013

Document Id: 9ac0ac54-7030-43f7-b22b-1a8f4fb33f6b

Set id: 0ad8745e-f682-4729-8917-15cb590a1226

Version: 3

Effective Time: 20130219

Mission Hills S.A de C.V