FDA.reportPublic FDA data

Crest Pro-Health HD

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2019-06-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:20:45

Label at a glance#

ProductCrest Pro-Health HD
Active ingredientSTANNOUS FLUORIDE
Label structure8 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

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 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.

WARNINGS 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. of age: ask 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
  • see your dentist regularly

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrated silica, water, zinc lactate, sodium lauryl sulfate, trisodium phosphate, flavor, sodium gluconate, sodium saccharin, xanthan gum, cellulose gum, sodium hydroxide, polyethylene, mica, titanium dioxide, blue 1

Questions?

OTC - QUESTIONS SECTION

(800) 492-7378

SPL UNCLASSIFIED SECTION

Dist. by Procter & Gamble,
Cincinnati, OH 45202

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TRY ME: TRIAL SIZE

Crest®

PRO-HEALTH™

[HD]™

FLUORIDE TOOTHPASTE FOR ANTICAVITY,
ANTIGINGIVITIS AND SENSITIVE TEETH
& WHITENING GEL

6X HEALTH IMPROVEMENT*

6X WHITENING IN 1 WEEK**

2-STEP SYSTEM

*gingivitis improvement vs. ordinary toothpaste
**improvement vs. ordinary toothpaste

1 TUBE NET WT 0.85 OZ (24 g) &
1 TUBE NET WT 0.68 OZ (19 g)

038038

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37000-03837000-038-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
ZINC LACTATE2GXR25858YIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM GLUCONATER6Q3791S76IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM HYDROXIDE55X04QC32IIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
ALUMINUM OXIDELMI26O6933IACT
STANNOUS FLUORIDE3FTR44B32QACTIM
WATER059QF0KO0RINGR
GLYCERINPDC6A3C0OXINGR
HYDROGEN PEROXIDEBBX060AN9VINGR
SODIUM ACID PYROPHOSPHATEH5WVD9LZUDINGR
SUCRALOSE96K6UQ3ZD4INGR
SODIUM HYDROXIDE55X04QC32IINGR

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
8bc25ff2-72ee-77e6-e053-2a95a90a54634756dfd8-aa21-44eb-e054-00144ff88e882019-06-20WarningsExact identifier
spl id: 8bc25ff2-72ee-77e6-e053-2a95a90a5463
spl set id: 4756dfd8-aa21-44eb-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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