Colgate Renewal Enamel Fortify

Manufacturer
Colgate-Palmolive Company
Effective date
2022-06-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:58:48

Label at a glance#

ProductColgate Renewal Enamel Fortify
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and 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

Dosage and administration

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.

Storage and handling

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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purposes

OTC - PURPOSE SECTION

Anticavity, Antigingivitis, Antisensitivity

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - STOP USE SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-22335000-223-63

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ac4855d1-3195-4eff-80ca-e2be915a01d1b1709679-e333-4c4d-9d7b-740647ebdc862022-06-22WarningsExact identifier
spl id: ac4855d1-3195-4eff-80ca-e2be915a01d1
spl set id: b1709679-e333-4c4d-9d7b-740647ebdc86

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.