FDA.reportPublic FDA data

Gum Purify

Manufacturer
Kroger | Lornamead
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:53:07

Label at a glance#

ProductGum Purify
Active ingredientSTANNOUS FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

OTC - PURPOSE SECTION

Anticavity/Antigingivitis

INDICATIONS & USAGE SECTION

*aids in the prevention of cavities * helps prevent gingivitis * helps interfree with the harmful effects of plaque associated with gingivitis * helps control plaque bacteria that contribute to the development of gingivitis

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 12 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years 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 years of age: ask a dentist

OTHER SAFETY INFORMATION

products containing stannous fluoride may produce surface staining of the teeth * adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist * this product is specifically formulated to help prevent staining * see your dentist regularly

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton R1Carton R1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-570GUM PURIFY (STANNOUS FLUORIDE) PASTE, DENTIFRICE [KROGER]5Legacy NDC20250119_cea6bd2d-a261-1209-e053-2995a90ab0a5.zip

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
30142-57030142-570-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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

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
2bee0434-d9c2-8ed7-e063-6294a90adbd4cea6bd2d-a261-1209-e053-2995a90ab0a52025-01-17WarningsExact identifier
spl id: 2bee0434-d9c2-8ed7-e063-6294a90adbd4
spl set id: cea6bd2d-a261-1209-e053-2995a90ab0a5

Reported adverse events (FAERS/openFDA)#

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