Made by Dentists Enamel 10 Fluoride Anticavity Toothpaste

Manufacturer
Made By Dentists Inc
Effective date
2026-09-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-26 01:01:53

Label at a glance#

ProductMade by Dentists Enamel 10 Fluoride Anticavity
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure8 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) or as recommended by a dentist or doctor.  Make sure to brush all sensitive areas of the teeth.  Children under 12 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredients :

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5.0%
Sodium Fluoride 0.24%
(0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

 Antisensitivity

 Anticavity

Use:

INDICATIONS & USAGE SECTION

Aids in the prevention of cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

Warnings:

WARNINGS SECTION

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 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) or as recommended by a dentist or doctor.
  •  Make sure to brush all sensitive areas of the teeth. 
  • Children under 12 years of age: Consult a dentist or doctor.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Cellulose Gum, Cocamidopropyl Betaine, Flavor, Hydrated Silica, Hydroxyapatite (Nano), Pentasodium Triphosphate, Potassium Sorbate, Sodium Bicarbonate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water (Aqua), Xylitol

Questions or comments?

OTC - QUESTIONS SECTION

+1 (646) 980-6461 | info@madebydentists.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Made by Dentists Enamel 10 Fluoride Anticavity Toothpaste, 120 g

Label 1Label 1

Inner Package1Inner Package1

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Made by Dentists Enamel 10 Fluoride Anticavity Toothpaste, 20 g

Label 2Label 2Label 2.1Label 2.1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850078838254GTIN-13: 0850078838254
EAN-13: 0850078838254
GTIN-12: 850078838254
UPC-A: 850078838254
GTIN storage (14 digits): 00850078838254
label 1.jpg

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75065-03375065-033-06, 75065-033-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-07-24daily-update2026-08-04 03:32:43

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
575e2c63-1fe6-2fde-e063-6294a90a28833c62eab1-0cb6-4bdf-bfd4-c5afe734d0362026-07-24WarningsExact identifier
spl set id: 3c62eab1-0cb6-4bdf-bfd4-c5afe734d036

Reported adverse events (FAERS/openFDA)#

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