COLGATE OPTIC WHITE STAIN FIGHTER WITH BAKING SODA- sodium fluoride paste, dentifrice

Colgate Optic White Stain Fighter by

Drug Labeling and Warnings

Colgate Optic White Stain Fighter 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, Hydrated Silica, Sorbitol, Glycerin, PEG-12, Pentasodium Triphosphate, Tetrapotassium Pyrophosphate, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Xanthan Gum, Sodium Hydroxide, Sodium Bicarbonate.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

ENAMEL SAFE
NET WT 6.0 OZ (170 g)

CLEAN MINT PASTE

NEW

OPTIC
WHITE®

STAIN FIGHTER®
WITH BAKING SODA

REMOVES 6X MORE SURFACE STAINS*
WITH MICRO-POLISHING ACTION

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE STAIN FIGHTER   WITH BAKING SODA
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-809
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)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

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: 35000-809-60	1 in 1 CARTON	11/15/2021
1		170 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-809-42	1 in 1 CARTON	11/15/2021
2		119 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	11/15/2021

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Hills, S.A. de C.V.		812312122	MANUFACTURE(35000-809) , ANALYSIS(35000-809) , PACK(35000-809) , LABEL(35000-809)