Colgate® Optic White® Renewal High Impact White

Colgate® Optic White® Renewal High Impact White

Drug Labeling and Warnings

Drug Details

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COLGATE OPTIC WHITE RENEWAL HIGH IMPACT WHITE- sodium monofluorophosphate paste, dentifrice 
Colgate-Palmolive Company

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® Renewal High Impact White

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, Hydrogen Peroxide, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Silica, Sucralose, BHT.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

NEW

OPTIC
WHITE®

RENEWAL

REMOVES
10 YEARS OF
YELLOW STAINS*

HYDROGEN
3%
PEROXIDE

HIGH IMPACT WHITE

NET WT 3.0 OZ (85 g)

ENAMEL SAFE

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
COLGATE OPTIC WHITE RENEWAL HIGH IMPACT WHITE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-982
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) 527 mg  in 1 g
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
POVIDONE K15 (UNII: E54VE15114)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM ACID PYROPHOSPHATE (UNII: H5WVD9LZUD)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35000-982-631 in 1 CARTON11/04/2019
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 35000-982-622 in 1 CARTON11/04/2019
285 g in 1 TUBE; Type 0: Not a Combination Product
3NDC: 35000-982-151 in 1 CARTON12/13/2019
320 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/04/2019
Labeler - Colgate-Palmolive Company (001344381)

Revised: 10/2019
 
Colgate-Palmolive Company


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