DR PLUS DENTAL DAILY CARE- sodium fluoride tablet, orally disintegrating

Dr Plus Dental Daily Care by

Drug Labeling and Warnings

Dr Plus Dental Daily Care by is a Otc medication manufactured, distributed, or labeled by EGUARDIAN MEDICARE TECH INC., JUHWANBIO.CELL CO.,LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium Fluoride 0.2% (0.09% w/v fluoride ion)

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use

Aids in the prevention of dental cavities

WARNINGS

Warnings

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If more than used for cleaning is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

adults and children 12 years and older - Chew an ingot and brush with an interdental brush or chew it until its fully dissolved in your mouth and its bubbles will gently cleansing your teeth, gargle with some water and spit it out to help maintain your oral hygiene at everywhere and anytime.

children 6 years to under 12 years of age - Supervise use.

children under 6 years - Do not use

INACTIVE INGREDIENT

Inactive ingredients 

Xylitol, Sorbitol, Malic Acid, Microcrystalline Cellulose, Lactose, Zea Mays (Corn) Starch, Sodium Bicarbonate, Magnesium Steartae, Calcium Carbonate, Titanium Dioxide, Lysine, Arginine, Menthol, Olea Europaea (Olive) Fruit Oil, Enzymatically Modified Stevia, Platycodon Grandiflorus Root Extract, Flavor, Hydroxypropyle Methylcellulose, Polyvinyl Alcohol, PEG-20, Gardenia Floride Extract, Camellia Sinensis (Green Tea) Leaf Extract, Vitis Vinifera (Grape) Skin Extract, Scutellaria Baicalensis Root Extract

QUESTIONS

Questions or comments? +886 2 2633 3456

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR PLUS DENTAL DAILY CARE 
sodium fluoride tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72382-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
SORBITOL (UNII: 506T60A25R)
MALIC ACID (UNII: 817L1N4CKP)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CALCIUM CARBONATE (UNII: H0G9379FGK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
LYSINE (UNII: K3Z4F929H6)
ARGININE (UNII: 94ZLA3W45F)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
OLIVE OIL (UNII: 6UYK2W1W1E)
PLATYCODON GRANDIFLORUS ROOT (UNII: 2DF0NS0O2Z)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
GARDENIA JASMINOIDES WHOLE (UNII: 0PK353KHF0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
VITIS VINIFERA ANTHOCYANINS (UNII: F02KPB2508)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)

Product Characteristics
Color	green (Light Green)	Score	no score
Shape	RECTANGLE	Size	11mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72382-001-03	1 in 1 CARTON	08/14/2018
1	NDC: 72382-001-02	12 in 1 BLISTER PACK
1	NDC: 72382-001-01	0.8 g in 1 CAPSULE; Type 0: Not a Combination Product
2	NDC: 72382-001-06	1 in 1 CARTON	08/14/2018
2	NDC: 72382-001-05	30 in 1 BLISTER PACK
2	NDC: 72382-001-04	0.8 g in 1 CAPSULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/14/2018

Labeler - EGUARDIAN MEDICARE TECH INC. (656394704)

Registrant - EGUARDIAN MEDICARE TECH INC. (656394704)

Establishment
Name	Address	ID/FEI	Business Operations
JUHWANBIO.CELL CO.,LTD.		690163444	manufacture(72382-001)