COLGATE RE RENEW- sodium fluoride 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® RE renew

Drug Facts

Active ingredient

Sodium Fluoride 0.24% (0.15% 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 the child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Calcium Pyrophosphate, PEG-12, Tetrapotassium Pyrophosphate, Sodium Lauryl Sulfate, Flavor, Potassium Hydroxide, Cellulose Gum, Phosphoric Acid, Xanthan Gum, Cocamidopropyl Betaine, Sodium Saccharin.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 107 g Tube Label

Colgate®

re:

re:new

whitening

fresh mint &
micro-polishers

anticavity fluoride toothpaste

NET WT 3.8 OZ (107 g)

P18133472

107 g Tube Label
COLGATE RE RENEW 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-744
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CALCIUM PYROPHOSPHATE (UNII: X69NU20D19)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-744-59107 g in 1 TUBE; Type 0: Not a Combination Product08/07/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/07/2021
Labeler - Colgate-Palmolive Company (001344381)

Revised: 7/2021
Document Id: cd6cd26f-d3ee-4ecf-bb4e-a456d22d564e
Set id: 679ffbd0-a4e1-9d03-1c88-1c4713b92a34
Version: 1
Effective Time: 20210721
 
Colgate-Palmolive Company