Drug Facts

Manufacturer
New World Imports, Inc
Effective date
2026-10-02
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-06 02:02:29

Label at a glance#

ProductFreshmint Sensitive
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure8 sections

Indications and uses

Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact. Aids in the prevention of dental cavities

Dosage and administration

Adults and children 12 years and older:   Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teet thoroughly for at least 1 minute twice a day (morning and evening), or as recommended by your dentist.  Make sure to brush all sensitive areas of the teeth.  Minimize swallowing.  Spit out after brushing Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate - 5%

Sodium Fluoride - 0.24%

Purpose

OTC - PURPOSE SECTION

Potassium Nitrate - Antihypersensitivity

Sodium Fluoride - Anticavity

Keep out of reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Uses

INDICATIONS & USAGE SECTION

Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Stop and ask a dentistif

  • The problem persists or worsens.  Sensitive teeth may indicate a serious problem that may require prompt care by a dentist
  • Pain / sensitivity still persists after 4 weeks of use

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older:  

  • Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
  • Brush teet thoroughly for at least 1 minute twice a day (morning and evening), or as recommended by your dentist.  Make sure to brush all sensitive areas of the teeth.  Minimize swallowing.  Spit out after brushing

Children under 12 years of age:consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Treated Water, PEG-32, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide, Trisodium Phosphate, Sodium Saccharin, Sodium Benzoate,  Color: D and C Yellow # 10, FD and C Blue # 1.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TPS43 Carton ArtworkTPS43 Carton Artwork

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
51824-05351824-053-01, 51824-053-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-12-01full-release2026-06-01 01:18:56

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
44ec0c63-58fc-bcc0-e063-6394a90a89e9aa2e0864-3325-4acf-a2c5-0eb27eb18baf2025-12-01WarningsExact identifier
spl set id: aa2e0864-3325-4acf-a2c5-0eb27eb18baf

Reported adverse events (FAERS/openFDA)#

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