Colgate® Optic White® High Impact Fluoride Toothpaste

Colgate Optic White High Impact Fluoride by

Drug Labeling and Warnings

Colgate Optic White High Impact Fluoride by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE OPTIC WHITE HIGH IMPACT FLUORIDE- 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® High Impact Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.12% 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, PVP, PEG/PPG-116/66 copolymer, PEG-12, glycerin, flavor, hydrogen peroxide, sodium lauryl sulfate, silica, tetrasodium pyrophosphate, sodium saccharin, disodium pyrophosphate, sucralose, phosphoric acid, BHT, water

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Colgate®

OPTIC
WHITE
®

PLATINUM
ANTICAVITY FLUORIDE TOOTHPASTE

NET WT
3.0 OZ (85 g)

NEW

HIGH IMPACT WHITE™

4 SHADES
VISIBLY WHITER*
STARTS WORKING IN 3 DAYS

ENAMEL SAFE
GLISTENING MINT

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
COLGATE OPTIC WHITE HIGH IMPACT FLUORIDE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65954-167
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) 401 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
POVIDONE K15 (UNII: E54VE15114)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-167-631 in 1 CARTON09/01/2015
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 65954-167-861 in 1 CARTON09/01/2015
2127 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35509/01/2015
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019