UNIDENTAL ALL CARETOOTHPASTE- sodium monofluorophosphate, cetylpyridinium chloride, potassium nitrate paste, dentifrice

Unidental All CareToothpaste by

Drug Labeling and Warnings

Unidental All CareToothpaste by is a Otc medication manufactured, distributed, or labeled by Unimed Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium monofluorophosphate, Cetylpyridinium chloride, Potassium nitrate

INACTIVE INGREDIENT

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

PURPOSE

■ 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

KEEP OUT OF REACH OF CHILDREN

keep out of reach of the children

INDICATIONS & USAGE

Brush your teeth with a suitable amount

WARNINGS

■ 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

dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNIDENTAL ALL CARETOOTHPASTE 
sodium monofluorophosphate, cetylpyridinium chloride, potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73669-012
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	3.75 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73669-012-01	100 g in 1 TUBE; Type 0: Not a Combination Product	04/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/20/2023

Labeler - Unimed Pharmaceuticals, Inc. (689852052)

Registrant - Unimed Pharmaceuticals, Inc. (689852052)

Establishment
Name	Address	ID/FEI	Business Operations
Unimed Pharmaceuticals, Inc.		689852052	label(73669-012) , manufacture(73669-012) , pack(73669-012)