Colgate® Optic White® Platinum™ Anticavity Fluoride Toothpaste

Colgate Optic White Platinum Anticavity Fluoride by

Drug Labeling and Warnings

Colgate Optic White Platinum Anticavity Fluoride 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 PLATINUM ANTICAVITY FLUORIDE- sodium monofluorophosphate 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.

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Colgate® Optic White® Platinum™ Anticavity Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% 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

propylene glycol, calcium pyrophosphate, glycerin, PEG/PPG-116/66 copolymer, PEG-12, PVP, silica, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, disodium pyrophosphate, hydrogen peroxide, sodium saccharin, sucralose, BHT

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 96 g Tube Carton

Colgate®

OPTIC
WHITE®
PLATINUM™
ANTICAVITY FLUORIDE TOOTHPASTE

LASTING
WHITE™

WHITENS AND SEALS
OUT EVEN TOUGH STAINS*

with WHITESEAL™ TECHNOLOGY

ENAMEL SAFE

COOL MINT

NET WT 3.4 OZ (96 g)

COLGATE OPTIC WHITE PLATINUM ANTICAVITY FLUORIDE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-589
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	338.1 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POVIDONE K15 (UNII: E54VE15114)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

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: 65954-589-93	1 in 1 CARTON	07/01/2015
1		96 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65954-589-86	1 in 1 CARTON	07/01/2015
2		127 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	07/01/2015

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

Revised: 4/2019

Document Id: 25c266c3-2e76-4903-b80c-20067f5a3155

34390-5

Set id: 62152942-44f1-4ea6-9d00-8aa3de2a084c

Version: 2

Effective Time: 20190416

 

Mission Hills S.A de C.V