COLGATE OPTIC WHITE BEAUTY RADIANT- sodium monofluorophosphate paste, dentifrice 
Mission Hills S.A de C.V

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colgate® Optic White Beauty™ Radiant™ Toothpaste

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

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

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

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)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label
COLGATE OPTIC WHITE BEAUTY RADIANT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-385
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-385-6385 g in 1 TUBE; Type 0: Not a Combination Product10/17/2016
2NDC:65954-385-161 in 1 CARTON10/17/2016
221.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35510/17/2016
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 10/2016
Document Id: c5b16209-af6f-414f-9f48-a01953e26ecd
Set id: 24109545-d251-4581-9af5-0120081bc227
Version: 1
Effective Time: 20161013
 
Mission Hills S.A de C.V