COLGATE GREAT REGULAR FLAVOR- sodium monofluorophosphate paste, dentifrice

COLGATE Great Regular Flavor by

Drug Labeling and Warnings

COLGATE Great Regular Flavor by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

COLGATE GREAT REGULAR FLAVOR  
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-913
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.0 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-913-20	24 g in 1 TUBE; Type 0: Not a Combination Product	11/05/2005
2	NDC: 35000-913-33	1 in 1 CARTON	11/05/2005
2		36.8 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-913-69	1 in 1 CARTON	11/05/2005
3		113 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-913-46	1 in 1 CARTON	11/05/2005
4		130 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-913-60	170 g in 1 TUBE; Type 0: Not a Combination Product	11/05/2005
6	NDC: 35000-913-64	1 in 1 CARTON	11/05/2005
6		181 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 35000-913-82	1 in 1 CARTON	11/05/2005
7		232 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 35000-913-04	4.25 g in 1 POUCH; Type 0: Not a Combination Product	11/05/2005
9	NDC: 35000-913-79	1 in 1 CARTON	11/05/2005
9		79 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC: 35000-913-93	99 g in 1 TUBE; Type 0: Not a Combination Product	11/05/2005
11	NDC: 35000-913-48	1 in 1 CARTON	11/05/2005
11		226 g in 1 TUBE; Type 0: Not a Combination Product
12	NDC: 35000-913-01	1 in 1 CARTON	11/05/2005
12		28 g in 1 TUBE; Type 0: Not a Combination Product
13	NDC: 35000-913-58	1 in 1 CARTON	11/05/2005
13		70 g in 1 TUBE; Type 0: Not a Combination Product
14	NDC: 35000-913-92	1 in 1 CARTON	11/05/2005
14		141 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - Colgate-Palmolive Company (001344381)