COLGATE RENEWAL ENAMEL FORTIFY- stannous 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® Renewal Enamel Fortify

Drug Facts

Active ingredient

Stannous Fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, Antigingivitis, Antisensitivity

Uses

  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with harmful effects of plaque associated with gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Warnings

When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.

Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.

Directions

  • adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth.
  • do not swallow.
  • children under 12 years of age: consult a dentist.

Other information

  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this Colgate product is specially formulated to help prevent staining.

Inactive ingredients

Sorbitol, Water, Hydrated Silica, PEG-12, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Potassium Nitrate, Xanthan Gum, Sodium Saccharin, Cocamidopropyl Betaine, Blue 1.

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Colgate®
Anticavity, Antigingivitis and Antisensitivity Toothpaste

NEW

RENEWAL

REVITALIZES
GUMS
BY REVERSING
EARLY DAMAGE

ENAMEL
FORTIFY

CLEAN MINT GEL
NET WT 3.0 OZ (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
COLGATE RENEWAL ENAMEL FORTIFY 
stannous fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-223
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (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)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-223-631 in 1 CARTON11/03/202003/09/2024
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/03/202003/09/2024
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive Company785047999ANALYSIS(35000-223) , LABEL(35000-223) , MANUFACTURE(35000-223) , PACK(35000-223)

Revised: 6/2022
Document Id: ac4855d1-3195-4eff-80ca-e2be915a01d1
Set id: b1709679-e333-4c4d-9d7b-740647ebdc86
Version: 4
Effective Time: 20220622
 
Colgate-Palmolive Company