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 older brush 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 years ask 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

www.colgateopticwhite.com

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

PRINCIPAL DISPLAY PANEL - 24 g Carton

NEW

Colgate®

OPTIC
WHITE

SAME WHITENING INGREDIENT AS STRIPS

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

NET WT 0.85 OZ (24 g)

SPARKLING MINT®

Principal Display Panel
COLGATE   OPTIC WHITE - SPARKLING MINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51442-552
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 7.6 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
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
Color WHITE Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51442-552-20 24 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 06/06/2011
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 6/2011
Document Id: decc5ca8-9818-48d1-ad7d-48662fd769c8
Set id: e0168b7e-7a4b-4a80-9172-3a3f8975df06
Version: 1
Effective Time: 20110603
 
Colgate-Palmolive Canada