COLGATE OPTIC WHITE SPARKLING MINT FLAVOR- 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® Sparkling Mint® Flavor Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% 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 yearsask a dentist or physician

Inactive ingredients

propylene glycol, calcium pyrophosphate, glycerin, PEG/PPG-116/66 copolymer, PEG-12, PVP, silica, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, hydrogen peroxide, disodium pyrophosphate, sodium saccharin, sucralose, BHT

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 141 g Tube Carton

Colgate®

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

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

NEW FORMULA

OPTIC
WHITE®

NET WT 5.0 OZ (141 g)

SPARKLING MINT®

Principal Display Panel - 141 g Tube Carton
COLGATE OPTIC WHITE SPARKLING MINT FLAVOR 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-771
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL341.6 mg  in 1 g
CALCIUM PYROPHOSPHATE 
GLYCERIN 
PEG/PPG-116/66 COPOLYMER 
POLYETHYLENE GLYCOL 600 
POVIDONE K15 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
SODIUM PYROPHOSPHATE 
HYDROGEN PEROXIDE 
SODIUM ACID PYROPHOSPHATE 
SACCHARIN SODIUM 
SUCRALOSE 
BUTYLATED HYDROXYTOLUENE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-771-771 in 1 CARTON
148 g in 1 TUBE
2NDC:65954-771-931 in 1 CARTON
299 g in 1 TUBE
3NDC:65954-771-921 in 1 CARTON
3141 g in 1 TUBE
4NDC:65954-771-951 in 1 CARTON
4178 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/18/2013
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 12/2013
Document Id: 274a60ad-ee33-471b-8595-8103936f8e11
Set id: 883c296d-75df-430e-87e5-dc4dd043e8b8
Version: 1
Effective Time: 20131216
 
Mission Hills S.A de C.V