Unidental All CareToothpaste

Manufacturer
Unimed Pharmaceuticals, Inc.
Effective date
2023-04-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:45

Label at a glance#

ProductUnidental All CareToothpaste
Active ingredientPOTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE, CETYLPYRIDINIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate, Cetylpyridinium chloride, Potassium nitrate

INACTIVE INGREDIENT SECTION

Sodium benzoate, Glycerin, Glycyrrhizin acid, Sodium
Copper Chlorophyllin, Sodium lauroyl sarcosinate, Menthol,
Myrrh tincture, Amorphous sorbitol solution(70%),
Saccharin sodium hydrate, Titanium dioxide, Sulfur, Sesin
Ext., Sage Ext., Mugwort Ext., Ascorbic acid, Titrated Ext.
of the unsaponifiable fraction of Zea mays L., Grapefruit
Seed Ext., Xylitol, Purified water, Carboxymethyl Cellulose
sodium, Chmomilla Extract, Bicarbonate sodium, Tocopheryl
acetate, Polyethylene glycol 1500, Propolis Ext.,
Pyrophosphate sodium, Pyridoxine Hydrochloride,
Hydroxyapatite, TIXOSIL 43K, Fragrance

OTC - PURPOSE SECTION

■ Prevention and reduction of tooth pain
■ Protection of sensitive teeth (tooth pain)
■ Tooth decay prevention
■ Dental plaque removal (anti-plaque)
■ Prevention of gingivitis and periodontitis
■ Keeping teeth white and strong
■ Keeping the inside of the mouth clean
■ Aesthetic effect

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

Brush your teeth with a suitable amount

WARNINGS SECTION

■ This toothpaste contains 1,000 ppm of fluoride
■ When used for children under the age of 6, use a very
small amount of toothpaste while teaching them not to
suck or swallow it
■ If a large amount is swallowed by a child under the age
of 6, consult a doctor or a dentist immediately
■ Keep out of reach of children under the age of 6

DOSAGE & ADMINISTRATION SECTION

dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73669-012-01Unidental All CareToothpaste100 g in 1 TUBEPASTE, DENTIFRICE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73669-012UNIDENTAL ALL CARETOOTHPASTE (SODIUM MONOFLUOROPHOSPHATE, CETYLPYRIDINIUM CHLORIDE, POTASSIUM NITRATE) PASTE, DENTIFRICE [UNIMED PHARMACEUTICALS, INC.]11 package rows20230421_f9bf72cb-56af-a128-e053-6394a90a3cb8.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73669-01273669-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
f9bf6820-2a0f-896e-e053-6394a90ae14cf9bf72cb-56af-a128-e053-6394a90a3cb82023-04-20WarningsExact identifier
spl id: f9bf6820-2a0f-896e-e053-6394a90ae14c
spl set id: f9bf72cb-56af-a128-e053-6394a90a3cb8

Reported adverse events (FAERS/openFDA)#

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