COLGATE OPTIC WHITE PRO SERIES STAIN PREVENTION- sodium monofluorophosphate paste, dentifrice

Colgate Optic White Pro Series Stain Prevention by

Drug Labeling and Warnings

Colgate Optic White Pro Series Stain Prevention by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Mission Hills, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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

Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Questions?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 59 g Tube Label

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®

PRO SERIES

REMOVES
15 YEARS
OF STAINS*

5%
HYDROGEN
PEROXIDE

STAIN PREVENTION

NET WT 2.1 OZ (59 g)

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE PRO SERIES STAIN PREVENTION 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-747
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLOXAMER 105 (UNII: XPP85ZHV76)	450.3 mg  in 1 g
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
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: 35000-747-30	1 in 1 CARTON	11/25/2021
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-747-32	1 in 1 CARTON	11/25/2021
2		93 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-747-21	1 in 1 CARTON	11/25/2021
3		59 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-747-16	1 in 1 CARTON	11/25/2021	12/31/2022
4		6 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 DRUG	M021	11/23/2021

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Hills, S.A. de C.V.		812312122	ANALYSIS(35000-747) , MANUFACTURE(35000-747) , PACK(35000-747) , LABEL(35000-747)