COLGATE OPTIC WHITE PLATINUM COOL MINT- sodium monofluorophosphate paste, dentifrice

Colgate Optic White Platinum by

Drug Labeling and Warnings

Colgate Optic White Platinum 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]

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 for 2 minutes, 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
www.colgateopticwhite.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 96 g Tube Label

Colgate®

OPTIC
WHITE®
PLATINUM

WHITEN
& PROTECT

WHITESEAL™ TECHNOLOGY

ANTICAVITY
FLUORIDE TOOTHPASTE

ENAMEL SAFE

COOL MINT

NET WT 3.4 OZ (96 g)

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE PLATINUM   COOL MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-588
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 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: 65954-588-93	1 in 1 CARTON
1		96 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	11/18/2013

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