Sensitivity Toothpastes

Manufacturer
Shenzhen Hengkaifeng Commerce and Trade Co., Ltd
Effective date
2024-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:39

Label at a glance#

ProductSensitivity Toothpastes
Active ingredientHYDRATED SILICA
Label structure9 sections

Dosage and administration

● adults and children 12 years of age and 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), 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:...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5%
Sodium Fluoride 0.1%

Purpose

OTC - PURPOSE SECTION

Antihypersensitivity
Anticavity

Use

INDICATIONS & USAGE SECTION

● builds increasing protection against painful sensitivity of the teeth to cold, heat, acids,
sweets, or contact.
● alds in the prevention cf dental cavities.

Warnings

WARNINGS SECTION

Stop use and ask a dentist if
● the problem persists or worsens. Sensitive teeth may indicate a serious problem that
may need prompt care by a dentist.
● pain/sensitivity still persists after 4 weeks of use.

Keep out of reach of children

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 Of Safe Use

DESCRIPTION SECTION


● adults and children 12 years of age and 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),
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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, glycerin, sorbitol, ethyl menthane carboxamide, titanium
dioxide, cellulose gum, sodium saccharin, sucralose

DOSAGE & ADMINISTRATION SECTION

apply at least a 1-inch strip of the product onto a soft bristle toothbrush.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0101

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84117-013-012026-01-29C16284748780-149896155-b01d-586f-e063-e6dba90add901c5a57cc-477d-c233-e063-6294a90aa062

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84117-013-01Sensitivity Toothpastes60 mL in 1 BOTTLELIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84117-013SENSITIVITY TOOTHPASTES LIQUID [SHENZHEN HENGKAIFENG COMMERCE AND TRADE CO., LTD]11 package rows20240704_1c5a57cc-477d-c233-e063-6294a90aa062.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84117-01384117-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9ACTIB

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
1c5a57cc-477e-c233-e063-6294a90aa0621c5a57cc-477d-c233-e063-6294a90aa0622024-07-03WarningsExact identifier
spl id: 1c5a57cc-477e-c233-e063-6294a90aa062
spl set id: 1c5a57cc-477d-c233-e063-6294a90aa062

Reported adverse events (FAERS/openFDA)#

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