Colgate® Optic White® High Impact Fluoride Toothpaste

Colgate Optic White High Impact Fluoride by

Drug Labeling and Warnings

Colgate Optic White High Impact 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 HIGH IMPACT 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® High Impact Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.12% 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, PVP, PEG/PPG-116/66 copolymer, PEG-12, glycerin, flavor, hydrogen peroxide, sodium lauryl sulfate, silica, tetrasodium pyrophosphate, sodium saccharin, disodium pyrophosphate, sucralose, phosphoric acid, BHT, water

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Colgate®

OPTIC
WHITE®

PLATINUM™
ANTICAVITY FLUORIDE TOOTHPASTE

NET WT
3.0 OZ (85 g)

NEW

HIGH IMPACT WHITE™

4 SHADES
VISIBLY WHITER*
STARTS WORKING IN 3 DAYS

ENAMEL SAFE
GLISTENING MINT

COLGATE OPTIC WHITE HIGH IMPACT FLUORIDE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-167
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)	401 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
POVIDONE K15 (UNII: E54VE15114)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SUCRALOSE (UNII: 96K6UQ3ZD4)
PHOSPHORIC ACID (UNII: E4GA8884NN)
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: 65954-167-63	1 in 1 CARTON	09/01/2015
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65954-167-86	1 in 1 CARTON	09/01/2015
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	09/01/2015

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

Revised: 4/2019

Document Id: 60b2d803-f6e4-4dce-86d6-1c9cb89de46f

34390-5

Set id: 62c73ae7-854f-40dc-8aa3-03f0ca5dedcf

Version: 2

Effective Time: 20190417