COLGATE RE REVIVE- sodium fluoride gel, 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 revive

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

Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Flavor, PEG-12, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Charcoal Powder, Blue 1, Red 40.

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:vive

polishes
teeth

fresh mint
& charcoal

anticavity fluoride toothpaste

NET WT 3.8 OZ (107 g)

P18133452

PRINCIPAL DISPLAY PANEL - 107 g Tube Label
COLGATE RE REVIVE 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-740
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
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Product Characteristics
ColorBLACKScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-740-59107 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: 2072229b-a95d-4a80-9f7a-45636d49bccf
Set id: 41f43ba2-b48e-1955-b804-06ae63226bc8
Version: 1
Effective Time: 20210720
 
Colgate-Palmolive Company