TP COL OW PURPLE- sodium fluoride paste, dentifrice

TP COL OW Purple by

Drug Labeling and Warnings

TP COL OW Purple by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Mission Hills, S.A. de C.V.. 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

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Blue 1, Red 33, Titanium Dioxide.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 70.8 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

Fresh Mint Paste

ENAMEL SAFE

Removes 95% of
Daily Surface Stains*

For a Brighter Smile

OPTIC
WHITE®

PURPLE

NET WT
2.5 OZ (70.8g)

INGREDIENTS AND APPEARANCE

TP COL OW PURPLE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-419
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
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-419-71	1 in 1 CARTON	10/01/2023
1		119 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-419-58	1 in 1 CARTON	04/01/2024
2		70.8 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 DRUG	M021	10/01/2023

Labeler - Colgate-Palmolive Company (001344381)

Registrant - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Hills, S.A. de C.V.		812312122	ANALYSIS(35000-419) , MANUFACTURE(35000-419) , PACK(35000-419) , LABEL(35000-419)