COLGATE OPTIC WHITE ADVANCED SPARKLING WHITE- sodium monofluorophosphate paste, dentifrice

Colgate Optic White Advanced Sparkling White by

Drug Labeling and Warnings

Colgate Optic White Advanced Sparkling White by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. 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, 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

PRINCIPAL DISPLAY PANEL - 127 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

NOW 2X WHITENING INGREDIENT†

OPTIC
WHITE®

ADVANCED

ENAMEL SAFE
NET WT 4.5 OZ (127 g)

SPARKLING WHITE®

DEEPLY WHITENS FOR
UP TO FOUR SHADES*

HYDROGEN
2%
PEROXIDE

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE ADVANCED SPARKLING WHITE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-978
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)	401.3 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: 35000-978-86	1 in 1 CARTON	10/14/2019
1		127 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-978-32	1 in 1 CARTON	10/14/2019
2		90 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-978-14	1 in 1 CARTON	10/14/2019
3		41 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-978-16	1 in 1 CARTON	10/14/2019
4		21.2 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-978-44	2 in 1 CARTON	10/14/2019
5		127 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 35000-978-76	2 in 1 CARTON	10/14/2019
6		90 g in 1 TUBE; Type 0: Not a Combination Product
7	NDC: 35000-978-71	1 in 1 CARTON	11/26/2019
7		119 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	10/14/2019

Labeler - Colgate-Palmolive Company (001344381)