COLGATE OPTIC WHITE STAIN PREVENTION- sodium monofluorophosphate paste, dentifrice

Colgate Optic White Stain Prevention by

Drug Labeling and Warnings

Colgate Optic White 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]

SPL UNCLASSIFIED SECTION

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, Hydrogen Peroxide (3% w/v), Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Disodium Pyrophosphate, Sodium Saccharin, Silica, Sucralose, BHT.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 121 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®
RENEWAL

10x
WHITER TEETH*

3%
HYDROGEN
PEROXIDE

STAIN PREVENTION

NET WT 4.3 OZ (121 g)
ENAMEL SAFE

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE STAIN PREVENTION 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-893
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)	527 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
POVIDONE K15 (UNII: E54VE15114)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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: 35000-893-43	1 in 1 CARTON	01/07/2022	12/31/2024
1		121 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-893-41	1 in 1 CARTON	01/07/2022
2		116 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	01/07/2022

Labeler - Colgate-Palmolive Company (001344381)

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