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

Colgate Optic White by

Drug Labeling and Warnings

Colgate Optic White 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]

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Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (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: as a dentist or physician

Inactive ingredients

calcium pyrophosphate, propylene glycol, PEG/PPG 116/66 copolymer, PEG-12, glycerin, PVP, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, silica, hydrogen peroxide, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 156 g Tube Carton Label

Colgate®

WHITER TEETH IN ONE WEEK

OPTIC
WHITE®

DAILY ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

NET WT 5.5 OZ (156 g)
COOL MILD MINT

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE   COOL MILD MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-560
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
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)	351.1 mg  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
GLYCERIN (UNII: PDC6A3C0OX)
POVIDONE K15 (UNII: E54VE15114)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SUCRALOSE (UNII: 96K6UQ3ZD4)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)

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: 65954-560-26	1 in 1 CARTON
1		156 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	01/02/2013

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