COLGATE OPTIC WHITE PRO SERIES- sodium monofluorophosphate paste, dentifrice

COLGATE OPTIC WHITE PRO SERIES by

Drug Labeling and Warnings

COLGATE OPTIC WHITE PRO SERIES 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]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium Monofluorophosphate 1.14% (0.18% 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 Contol Center right away.

Directions

• adults and children 6 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 6 to 12 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
• children under 6 years: do not use unless directed by a dentist or physician

Inactive ingredients

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

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

2
VALUE
PACK

OPTIC
WHITE®

PRO SERIES

REMOVES
15 YEARS
OF DEEP-SET STAINS*

ACTIVSHINE
TECHNOLOGY

5%
HYDROGEN
PEROXIDE

ENAMEL RENEWAL

PASTE
SOOTHING MINT

TWO 3.0 OZ (85 g) TUBES TOTAL NET WT 6.0 OZ (170 g)
ENAMEL SAFE

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE PRO SERIES 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-845
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	11.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	560.3 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)
WATER (UNII: 059QF0KO0R)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
POVIDONE K30 (UNII: U725QWY32X)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
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: 65954-845-63	1 in 1 CARTON	11/24/2025
1		85 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65954-845-62	2 in 1 CARTON	11/24/2025
2		85 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	M022	11/24/2025

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

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