FDA.reportPublic FDA data

Crest Pro-Health

Manufacturer
The Procter & Gamble Manufacturing Company
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:52:14

Label at a glance#

ProductCrest Pro-Health Gum Rescue Pro Soothing Clean
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

Dosage and administration

adults and children 12 yrs. of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. • do not swallow • children under 12 yrs. of age: ask 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 Crest is specially formulated to help prevent staining see your dentist regularly

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 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

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 12 yrs.
of age. 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. of age and
    older: Brush teeth thoroughly, preferably
    after each meal or at least twice a day, or
    as directed by a dentist or physician.
    • 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
  • this Crest is specially formulated to help prevent staining
  • see your dentist regularly

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-594-4158

SPL UNCLASSIFIED SECTION

DISTR. BY PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 130 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LARGE

SIZE

Crest

PRO-HEALTH

FLUORIDE TOOTHPASTE FOR
ANTICAVITY AND ANTIGINGIVITIS

GUM

RESCUE

ACTIVELY REVERSES WEAK

SPOTS, EVEN IN AREAS OF

RECESSION

SOOTHING CLEANSE

CLINICALLY PROVEN

BETTER GUM HEALTH

NET WT 4.6 OZ (130 g)

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN5
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD5
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY5
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY5
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-609-46Crest Pro-HealthGum Rescue Pro Soothing Clean1 in 1 CARTONPASTE, DENTIFRICE15
84126-609-46Crest Pro-HealthGum Rescue Pro Soothing Clean130 g in 1 TUBEPASTE, DENTIFRICE1305

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84126-60984126-609-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCINETE7660XO1CIACT
SUCRALOSE96K6UQ3ZD4IACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
SODIUM CITRATE1Q73Q2JULRIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM GLUCONATER6Q3791S76IACT
CARRAGEENAN5C69YCD2YJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
ZINC CITRATEK72I3DEX9BIACT
SODIUM HYDROXIDE55X04QC32IIACT
STANNOUS CHLORIDE1BQV3749L5IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42026-01-06full-release2026-06-01 01:31:41

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
Crest Pro-Health Gum Rescue Pro Soothing CleanSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company2f10c7ac-eb60-011e-e063-6394a90aca132026-01-08WarningsExact identifier
ndc (package): 84126-609-46
ndc (product): 84126-609
ndc11 (package): 84126060946
spl id: 47e53483-0dbf-e448-e063-6394a90a6cd1
spl set id: 2f10c7ac-eb60-011e-e063-6394a90aca13

Reported adverse events (FAERS/openFDA)#

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