Colgate® Optic White® Icy Fresh Cool Fresh Mint Fluoride Toothpaste

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]

COLGATE OPTIC WHITE  ICY FRESH COOL FRESH MINT- 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® Icy Fresh Cool Fresh Mint Fluoride Toothpaste

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, hydrogen peroxide, disodium pyrophosphate, sodium saccharin, sucralose, BHT

Questions?

1-800-468-6502
www.colgateopticwhite.com

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

PRINCIPAL DISPLAY PANEL - 178 g Tube Label

Colgate®

WHITER TEETH IN 1 WEEK
GOES BEYOND SURFACE STAIN REMOVAL TO DEEPLY WHITEN

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

NET WT 6.3 OZ (178 g)

OPTIC
WHITE®

ICY FRESH

COOL FRESH MINT

COLGATE OPTIC WHITE   ICY FRESH COOL FRESH MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-769
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)	344.1 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)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
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: 65954-769-95	1 in 1 CARTON	11/18/2013
1		178 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65954-769-93	1 in 1 CARTON	11/18/2013
2		99 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 65954-769-92	1 in 1 CARTON	11/18/2013
3		141 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	11/18/2013

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

Revised: 4/2019

Document Id: 44249612-15a7-4db7-a40a-8e432a03f3c4

34390-5

Set id: f2eab3d2-2dc7-40e2-a6a9-ca540c6403e1

Version: 2

Effective Time: 20190416

 

Mission Hills S.A de C.V