Colgate Total SF Advanced Whitening

Manufacturer
Colgate-Palmolive Company
Effective date
2024-09-27
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:22:15

Label at a glance#

ProductColgate Total SF Advanced Whitening
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 persist 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

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Microcrystalline Cellulose, Cellulose Gum, Zinc Phosphate, Sodium Citrate, Cocamidopropyl Betaine, Propylene Glycol, Sodium Saccharin, Xanthan Gum, Citric Acid, Sucralose, Titanium Dioxide.

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 - 181 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity, Antigingivitis and Antisensitivity Toothpaste

ADA
Accepted
American
Dental
Association ®

24-Hour Antibacterial Protection†
✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL
✓TARTAR ✓FRESH BREATH ✓WHITENS ✓SENSITIVITY RELIEF

Total

ADVANCED
WHITENING

NET WT 6.4 OZ (181 g)

PASTE

Principal Display Panel - 181 g Tube Carton
Principal Display Panel - 181 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN14
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD14
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY14
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY14
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-178-14Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-14Colgate Total SF Advanced Whitening39.6 g in 1 TUBEPASTE, DENTIFRICE39.614
35000-178-18Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-18Colgate Total SF Advanced Whitening5 in 1 CELLO PACKPASTE, DENTIFRICE514
35000-178-25Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-25Colgate Total SF Advanced Whitening24.9 g in 1 TUBEPASTE, DENTIFRICE24.914
35000-178-47Colgate Total SF Advanced Whitening144 g in 1 TUBEPASTE, DENTIFRICE14414
35000-178-47Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-64Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114
35000-178-64Colgate Total SF Advanced Whitening181 g in 1 TUBEPASTE, DENTIFRICE18114
35000-178-65Colgate Total SF Advanced Whitening144 g in 1 TUBEPASTE, DENTIFRICE14414
35000-178-65Colgate Total SF Advanced Whitening2 in 1 CARTONPASTE, DENTIFRICE214
35000-178-93Colgate Total SF Advanced Whitening96 g in 1 TUBEPASTE, DENTIFRICE9614
35000-178-93Colgate Total SF Advanced Whitening1 in 1 CARTONPASTE, DENTIFRICE114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-178COLGATE TOTAL SF ADVANCED WHITENING (STANNOUS FLUORIDE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]14Current NDC, Legacy NDC, 14 package rows20240929_f8aeac8e-6a3e-4ada-bb13-db337b934ba3.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-17835000-178-25, 35000-178-93, 35000-178-47, 35000-178-65, 35000-178-64, 35000-178-14, 35000-178-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
Colgate Total SF Advanced WhiteningSTANNOUS FLUORIDEColgate-Palmolive Companyf8aeac8e-6a3e-4ada-bb13-db337b934ba32024-09-27WarningsExact identifier
ndc (package): 35000-178-25
ndc (package): 35000-178-93
ndc (package): 35000-178-14
ndc (package): 35000-178-47
ndc (package): 35000-178-18
ndc (package): 35000-178-65
ndc (package): 35000-178-64
ndc (product): 35000-178
ndc11 (package): 35000017893
ndc11 (package): 35000017864
ndc11 (package): 35000017865
ndc11 (package): 35000017814
ndc11 (package): 35000017818
ndc11 (package): 35000017847
ndc11 (package): 35000017825
spl id: 54eebf5f-0d5a-40d0-9b4f-fface020bc3d
spl set id: f8aeac8e-6a3e-4ada-bb13-db337b934ba3

Reported adverse events (FAERS/openFDA)#

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