COLGATE OPTIC WHITE SPARKLING MINT FLAVOR- sodium monofluorophosphate paste, dentifrice 
Team Technologies, Inc

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

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 DRUGItem Code (Source)NDC:67659-330(NDC:65954-771)
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) 341.6 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
GLYCERIN (UNII: PDC6A3C0OX)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POVIDONE K15 (UNII: E54VE15114)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67659-330-04178 g in 1 TUBE; Type 1: Convenience Kit of Co-Package05/20/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35512/18/2013
Labeler - Team Technologies, Inc (192339703)
Registrant - Team Technologies, Inc (192339703)
Establishment
NameAddressID/FEIBusiness Operations
Team Technologies, Inc079337800relabel(67659-330) , repack(67659-330)

Revised: 5/2016
Document Id: 33484705-de4c-5ead-e054-00144ff88e88
Set id: 33484705-de4b-5ead-e054-00144ff88e88
Version: 1
Effective Time: 20160520
 
Team Technologies, Inc