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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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 Label

NEW

Colgate®

SAME WHITENING INGREDIENT AS STRIPS
WHITER TEETH IN 1 WEEK

OPTIC
WHITE™

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

NET WT 4.0 OZ (113 g)
COOL MILD MINT

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton Label
COLGATE OPTIC WHITE   COOL MILD MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-560
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM PYROPHOSPHATE351.1 mg  in 1 g
PROPYLENE GLYCOL 
POLYETHYLENE GLYCOL 600 
GLYCERIN 
POVIDONE K15 
SODIUM LAURYL SULFATE 
SODIUM PYROPHOSPHATE 
SILICON DIOXIDE 
HYDROGEN PEROXIDE 
SACCHARIN SODIUM DIHYDRATE 
PHOSPHORIC ACID 
SUCRALOSE 
BUTYLATED HYDROXYTOLUENE 
WATER 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
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: 05/2012
Document Id: d1e3f9b9-56c0-4e51-b10f-fb591d6cd823
Set id: d0e45503-b83b-4a86-8289-b64b389f8ce7
Version: 1
Effective Time: 20120525
 
Mission Hills S.A de C.V