Crest Pro-Health

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2023-05-19
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:31:06

Label at a glance#

ProductCrest Pro-Health
Active ingredientSTANNOUS FLUORIDE
Label structure10 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#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Stannous fluoride 0.454%

(0.14% 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

When using this product do not use for sensitivity longer than four 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.

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

WARNINGS AND PRECAUTIONS 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

water, sorbitol, hydrated silica, sodium lauryl sulfate, carrageenan, sodium gluconate, flavor, xanthan gum, zinc citrate, stannous chloride, sodium saccharin, sodium hydroxide, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,

CINCINNATI, OH 45202

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SMOOTH FORMULA

Crest® PRO-HEALTH™

FLUORIDE TOOTHPASTE FOR ANTICAVITY, ANTIGINGIVITIS AND SENSITIVE TEETH

SMOOTH PEPPERMINT

CAVITIES | GINGIVITIS | SENSITIVITY | PLAQUE TARTAR | WHITENING | FRESHENS BREATH

NET WT 4.6 OZ (130g)

884884

FDA-Initiated Inactive NDC Indexing#

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-88437000-884-04, 37000-884-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
026b4bc1-9382-86e1-e063-6294a90a0d9f429b2656-49e1-2a67-e054-00144ff8d46c2023-08-08WarningsExact identifier
spl set id: 429b2656-49e1-2a67-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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