Colgate® Optic White® Stain Fighter™ Clean Mint

Colgate Optic White Stain Fighter Clean Mint by

Drug Labeling and Warnings

Colgate Optic White Stain Fighter Clean Mint by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE OPTIC WHITE STAIN FIGHTER CLEAN MINT- sodium fluoride paste, dentifrice 
Mission Hills S.A de C.V

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Colgate® Optic White® Stain Fighter™ Clean Mint

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, titanium dioxide

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

NEW
STAIN REMOVAL
TECHNOLOGY**

Colgate®

OPTIC
WHITE®

STAIN FIGHTER™

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

NET WT 4.2 OZ (119 g)
ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE WHITENING

CLEAN MINT PASTE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-403
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
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)
XANTHAN GUM (UNII: TTV12P4NEE)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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: 65954-403-71	1 in 1 CARTON	11/30/2017
1		119 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65954-403-02	1 in 1 CARTON	11/30/2017
2		56.6 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 65954-403-60	1 in 1 CARTON	12/19/2018
3		170 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	11/30/2017

Labeler - Mission Hills S.A de C.V (812312122)

Revised: 12/2018

Document Id: 2f80e535-e820-4a6a-b94a-0b9297c75cf1

34390-5

Set id: 1726a2d2-8580-4059-81ec-bbfb3af79492

Version: 2

Effective Time: 20181218

 

Mission Hills S.A de C.V