COLGATE CAVITY PROTECTION GREAT REGULAR FLAVOR- anticavity fluoride toothpaste paste, dentifrice

Colgate Cavity Protection Great Regular Flavor by

Drug Labeling and Warnings

Colgate Cavity Protection Great Regular Flavor by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Colgate-Palmolive (Thailand) Limited - Branch. 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 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?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 226 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

Cavity
Protection

NET WT 8.0 OZ (226 g)

ADA
Accepted
American
Dental
Association ®

Strengthens Teeth
with Active Fluoride

Great Regular Flavor

INGREDIENTS AND APPEARANCE

COLGATE CAVITY PROTECTION GREAT REGULAR FLAVOR 
anticavity fluoride toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-060
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 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-060-48	226 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	01/22/2026

Labeler - Colgate-Palmolive Company (001344381)

Registrant - Colgate-Palmolive (Thailand) Limited - Branch (672044552)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive (Thailand) Limited - Branch		672044552	ANALYSIS(35000-060) , MANUFACTURE(35000-060) , PACK(35000-060) , LABEL(35000-060)