COLGATE  OPTIC WHITE - SPARKLING MINT- sodium monofluorophosphate paste, dentifrice 
Colgate-Palmolive Canada

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™

Drug Facts

Active ingredients

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

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 years use 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

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

PRINCIPAL DISPLAY PANEL - 113 g Carton

Colgate®

SAME WHITENING INGREDIENT AS STRIPS
WHITER TEETH IN 1 WEEK

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

NET WT 4.0 OZ (113 g)

NEW

OPTIC
WHITE™

SPARKLING MINT®

Principal Display Panel - 113 g Carton
COLGATE   OPTIC WHITE - SPARKLING MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-552
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
Glycerin (UNII: PDC6A3C0OX)  
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:51442-552-691 in 1 CARTON06/06/201106/01/2019
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/06/201106/01/2019
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 9/2019
Document Id: 71305dc6-849b-4f80-b1b1-f4162800192e
Set id: 8698e7f7-582a-407f-a5d8-17a37ba2c2de
Version: 2
Effective Time: 20190909
 
Colgate-Palmolive Canada