FDA.reportPublic FDA data

Natural White Sensitivity and Gum

Manufacturer
Lornamead Products
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:16:02

Label at a glance#

ProductNatural White Sensitivity and Gum
Active ingredientSTANNOUS FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

OTC - PURPOSE SECTION

Anticavity, Antigingivitis, Antihypersensitivity

OTC - PURPOSE SECTION

  • aids in the prevention of dental cavities
  • helps interfere with the harmful effects of plaque associated with gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

WARNINGS SECTION

OTC - WHEN USING SECTION

When using this product, if irritation occurs discontinue use.

OTC - STOP USE SECTION

Stop use and ask a dentist if:

  • the problem persists or worsens. Sensitive teeths may indicate a serious problem that may need prompt care by a dentist
  • pain/sensitivity still persists after 4 weeks of use
  • gingivitis, bleeding, or redness persists formore that 2 weeks
  • you have painful or swollen gums,pus from the gum line, loose teeth, or increasinf space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 12 years of age and older: apply at least 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), and not more than 3 times a day, or as recommended by a dentist or doctor. make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • children under 12 years of age: Consult a dentist or doctor.

OTHER SAFETY INFORMATION

Other 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.

INACTIVE INGREDIENT SECTION

Inactive ingredients glycerin, water, hydrated silica pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamidopropyl betaine, sodium saccharin

INDICATIONS & USAGE SECTION

Directions

adults and children 12 years of age and older: apply at least 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), and not more than 3 times a day, or as recommended by a dentist or doctor. make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

  • children under 12 years of age: Consult a dentist or doctor.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NW_SensitivityGum_Ctn_2011572R1NW_SensitivityGum_Ctn_2011572R1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN4
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD4
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY4
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY4
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130067990009031GTIN-13: 0067990009031
EAN-13: 0067990009031
GTIN-12: 067990009031
UPC-A: 067990009031
GTIN storage (14 digits): 00067990009031		NW_SenstivityGum_Carton_2011572R1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62721-0003-1Natural White Sensitivity and Gum85 g in 1 TUBEPASTE, DENTIFRICE854
62721-0003-1Natural White Sensitivity and Gum1 in 1 CARTONPASTE, DENTIFRICE14

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62721-000362721-0003-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
HYDRATED SILICAY6O7T4G8P9IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM SACCHARINSB8ZUX40TYIACT
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
Natural White Sensitivity and GumSTANNOUS FLUORIDELornamead Products2e83bda8-4d4b-640f-e063-6294a90abc602025-11-14WarningsExact identifier
ndc (package): 62721-0003-1
ndc (product): 62721-0003
ndc11 (package): 62721000301
spl id: 43956f49-90be-5b18-e063-6294a90aad71
spl set id: 2e83bda8-4d4b-640f-e063-6294a90abc60

Reported adverse events (FAERS/openFDA)#

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