FDA.reportPublic FDA data

Crest Sensitvity

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-05-31
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:30:35

Label at a glance#

ProductCrest Sensitvity Complete Protection
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

adults and children 12 yrs. & older: apply at least a 1-inch strip of the product onto a soft bristle 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 yrs.: ask a dentist

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.16% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Anticavity, antigingivitis, antisensitivity toothpaste

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with the harmful effects of plaque associated with gingivitis
  • helps control plaque bacteria that contribute to the development of 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 do not use for sensitivity longer than four 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.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 yrs. & older: apply at least a 1-inch strip of the product onto a soft bristle 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 yrs.: ask a dentist

Other information

SPL UNCLASSIFIED 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 Crest is specially formulated to help prevent staining
  • see your dentist regularly

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, sodium hexametaphosphate, propylene glycol, PEG-6, water, zinc lactate, water, flavor, trisodium phosphate, sodium lauryl sulfate, sodium gluconate, carrageenan, sodium saccharin, xanthan gum, blue 1

Questions?

OTC - QUESTIONS SECTION

1-800-492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - 170g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Crest®

PRO-HEALTH
SENSITIVITY

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

NET WT 6.0 OZ (170 g)

REPAIRS* PAINFUL SENSITIVITY

PREVENTS FUTURE SENSITIVITY

COMPLETE

PROTECTION
SMOOTH MINT
BUILDS A THERAPEUTIC & PROTECTIVE LAYER

899N899N

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-89937000-899-35, 37000-899-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
WATER059QF0KO0RIACT
ZINC LACTATE2GXR25858YIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM GLUCONATER6Q3791S76IACT
CARRAGEENAN5C69YCD2YJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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
2b383204-d469-4def-e063-6294a90a8efa626e510c-a60f-7553-e053-2a91aa0afa762025-01-08WarningsExact identifier
spl set id: 626e510c-a60f-7553-e053-2a91aa0afa76

Reported adverse events (FAERS/openFDA)#

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