COLGATE TRIPLE ACTION- sodium fluoride paste, dentifrice

Colgate Triple Action by

Drug Labeling and Warnings

Colgate Triple Action by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive, Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium fluoride 0.24% (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

sorbitol, water, hydrated silica, sodium lauryl sulfate, flavor, PEG-12, tetrasodium pyrophosphate, cocamidopropyl betaine, cellulose gum, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE
COMPANY
New York 10022

PRINCIPAL DISPLAY PANEL - 232 g Tube Carton

Three Benefits for a Deep Clean

Colgate®
Fluoride Toothpaste

NET WT 8.2 OZ (232 g)

Triple
Action

Original Mint

Cavity
Protection
1

Whiter
Teeth
2

Fresh
Breath
3

INGREDIENTS AND APPEARANCE

COLGATE TRIPLE ACTION 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-941
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDRATED SILICA (UNII: Y6O7T4G8P9)	220 mg  in 1 g
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-941-79	1 in 1 CARTON	12/01/2010
1		79 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-941-63	1 in 1 CARTON	12/01/2010
2		85 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-941-69	1 in 1 CARTON	12/01/2010
3		113 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-941-46	1 in 1 CARTON	12/01/2010
4		130 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-941-64	1 in 1 CARTON	12/01/2010
5		181 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 35000-941-82	1 in 1 CARTON	12/01/2010
6		232 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 35000-941-60	1 in 1 CARTON	12/01/2010
7		170 g in 1 TUBE; Type 0: Not a Combination Product
8	NDC: 35000-941-48	1 in 1 CARTON	12/01/2010
8		226 g in 1 TUBE; Type 0: Not a Combination Product
9	NDC: 35000-941-58	1 in 1 CARTON	12/01/2010
9		70 g in 1 TUBE; Type 0: Not a Combination Product
10	NDC: 35000-941-92	1 in 1 CARTON	12/01/2010
10		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	12/01/2010

Labeler - Colgate-Palmolive Company (001344381)