DR.ALTHEA I AM NATURAL TOOTHPASTEFORADULTS- sodium monofluorophosphate paste, dentifrice

Dr.Althea I am Natural ToothpasteForAdults by

Drug Labeling and Warnings

Dr.Althea I am Natural ToothpasteForAdults by is a Otc medication manufactured, distributed, or labeled by Dr. Althea, Kumho Dental Pharm Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

SODIUM MONOFLUOROPHOSPHATE, SILICA, PYRIDOXINE HCI, ALCLOXA

PURPOSE

Aids in the prevention of dental cavities.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

How to use:

1) Squeeze toothpaste on to toothbrush.
2) Brush thoroughly at least twice a day.
3) Brush for 3+ minutes.
4) Rinse out thoroughly with water.

Directions

■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

■ Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

■ Supervise children as necessary until capable of using without supervision.

■ Children under 2 years of age: Consult a dentist or doctor.

WARNINGS

Cautions:
1) If following symptoms occur after product use, stop using immediately: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT

SILVER, HYDRATED SILICA, CELLULOSE GUM, SORBITIOL, GLYCERIN, PEG-32, XYLITOL, MENTHOL, WATER, ETC.

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.ALTHEA I AM NATURAL TOOTHPASTEFORADULTS 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70905-0017
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70905-0017-1	120 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/01/2018

Labeler - Dr. Althea (689694436)

Registrant - Dr. Althea (689694436)

Establishment
Name	Address	ID/FEI	Business Operations
Kumho Dental Pharm Co Ltd		631133766	manufacture(70905-0017)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. Althea		689694436	label(70905-0017)