Colgate® Optic White® Sparkling Mint® Flavor Toothpaste

Colgate Optic White Sparkling Mint Flavor by

Drug Labeling and Warnings

Colgate Optic White Sparkling Mint Flavor 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 SPARKLING MINT FLAVOR- 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® Sparkling Mint® Flavor 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, hydrogen peroxide, disodium pyrophosphate, sodium saccharin, sucralose, BHT

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

Colgate®

WHITER TEETH
IN 1 WEEK

OPTIC
WHITE®

ADVANCED WHITENING
WITH HYDROGEN PEROXIDE TO
DEEPLY WHITEN

NET WT 4.6 OZ (130 g)

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

SPARKLING WHITE®

COLGATE OPTIC WHITE SPARKLING MINT FLAVOR 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-771
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)	341.6 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: 65954-771-77	1 in 1 CARTON	12/18/2013
1		48 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65954-771-93	1 in 1 CARTON	12/18/2013
2		99 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 65954-771-92	1 in 1 CARTON	12/18/2013
3		141 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 65954-771-95	1 in 1 CARTON	12/18/2013
4		178 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 65954-771-20	1 in 1 CARTON	12/18/2013
5		24 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 65954-771-11	1 in 1 CARTON	06/01/2016
6		32.6 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 65954-771-46	1 in 1 CARTON	03/19/2018
7		130 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	12/18/2013

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

Revised: 3/2018

Document Id: 6a215cf8-f58e-4fb0-9681-a0b8cfad1db3

34390-5

Set id: 883c296d-75df-430e-87e5-dc4dd043e8b8

Version: 5

Effective Time: 20180314

 

Mission Hills S.A de C.V