COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT- sodium fluoride paste, dentifrice

Colgate Optic White Stain Fighter Fresh Mint by

Drug Labeling and Warnings

Colgate Optic White Stain Fighter Fresh Mint 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, Sodium Saccharin, Benzyl Alcohol, Mica, Blue 1, Titanium Dioxide.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®

STAIN FIGHTER®

REMOVES 5X MORE SURFACE STAINS*
WITH MICRO-POLISHING ACTION

FRESH MINT GEL
ENAMEL SAFE
NET WT 2.0 OZ (56.6 g)

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINT 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-263
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 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	191.18 mg  in 1 g
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
PHOSPHORIC ACID (UNII: E4GA8884NN)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MICA (UNII: V8A1AW0880)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-263-71	1 in 1 CARTON	06/01/2022	12/31/2024
1		119 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-263-02	1 in 1 CARTON	06/01/2022	12/31/2024
2		56.6 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-263-60	1 in 1 CARTON	06/01/2022	12/31/2024
3		170 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-263-33	1 in 1 CARTON	06/01/2022	12/31/2024
4		36.8 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-263-30	1 in 1 CARTON	06/01/2022	12/31/2024
5		85 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	06/01/2022	12/31/2024

Labeler - COLGATE PALMOLIVE COMPANY (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Hills, S.A. de C.V.		812312122	ANALYSIS(35000-263) , MANUFACTURE(35000-263) , PACK(35000-263) , LABEL(35000-263)