COLGATE OPTIC WHITE  COOL MILD MINT- 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 Cool Mild Mint Fluoride Toothpaste 4.0OZ

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% 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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsas a dentist or physician

Inactive ingredients

calcium pyrophosphate, propylene glycol, PEG/PPG 116/66 copolymer, PEG-12, glycerin, PVP, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, silica, hydrogen peroxide, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

Colgate®

WHITER TEETH IN 1 WEEK
GOES BEYOND SURFACE STAIN REMOVAL TO DEEPLY WHITEN

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

OPTIC
WHITE®

NET WT 4.0 OZ (113 g)
COOL MILD MINT

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
COLGATE OPTIC WHITE   COOL MILD MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-560
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
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19) 351.1 mg  in 1 g
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
GLYCERIN (UNII: PDC6A3C0OX)  
POVIDONE K15 (UNII: E54VE15114)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-560-691 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/2012
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 10/2013
Document Id: 889e3730-c9d4-475a-8ff2-60e21fab33b0
Set id: d0e45503-b83b-4a86-8289-b64b389f8ce7
Version: 2
Effective Time: 20131015
 
Mission Hills S.A de C.V