COLGATE OPTIC WHITE BEAUTY RADIANT- sodium monofluorophosphate paste, dentifrice

Colgate Optic White Beauty Radiant by

Drug Labeling and Warnings

Colgate Optic White Beauty Radiant 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]

Active ingredient

Sodium monofluorophosphate 1.14% (0.19% 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 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: instruct in good brushing and rinsing habits (to minimize swallowing)
• children under 6 years: do not use unless directed by 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, disodium pyrophosphate, sodium saccharin, zinc oxide, citric acid, sucralose, BHT

SPL UNCLASSIFIED SECTION

Some people may experience tooth sensitivity or gum discomfort when using whitening products. This discomfort is temporary and not harmful. If you experience more than mild tooth sensitivity, stop use and consult your dentist.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

RADIANT™

WHITENS INSIDE & OUT
FOR A RADIANT SMILE

Colgate®

OPTIC
WHITE
BEAUTY™

ANTICAVITY FLUORIDE TOOTHPASTE
ENAMEL SAFE
ICY MINT

NET WT 3.0 OZ (85 g)

INGREDIENTS AND APPEARANCE

COLGATE OPTIC WHITE BEAUTY RADIANT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-385
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)	392.5 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)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ZINC OXIDE (UNII: SOI2LOH54Z)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
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: 65954-385-63	85 g in 1 TUBE; Type 0: Not a Combination Product	10/17/2016
2	NDC: 65954-385-16	1 in 1 CARTON	10/17/2016
2		21.2 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	10/17/2016

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