DR PLUS DENTAL DAILY CARE- sodium fluoride tablet, orally disintegrating 
EGUARDIAN MEDICARE TECH INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Dr Plus Dental Daily Care

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

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

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.

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 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 or comments? +886 2 2633 3456

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DR PLUS DENTAL DAILY CARE 
sodium fluoride tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72382-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
Colorgreen (Light Green) Scoreno score
ShapeRECTANGLESize11mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72382-001-031 in 1 CARTON08/14/2018
1NDC:72382-001-0212 in 1 BLISTER PACK
1NDC:72382-001-010.8 g in 1 CAPSULE; Type 0: Not a Combination Product
2NDC:72382-001-061 in 1 CARTON08/14/2018
2NDC:72382-001-0530 in 1 BLISTER PACK
2NDC:72382-001-040.8 g in 1 CAPSULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/14/2018
Labeler - EGUARDIAN MEDICARE TECH INC. (656394704)
Registrant - EGUARDIAN MEDICARE TECH INC. (656394704)
Establishment
NameAddressID/FEIBusiness Operations
JUHWANBIO.CELL CO.,LTD.690163444manufacture(72382-001)

Revised: 8/2018
Document Id: 736ee790-99fe-686c-e053-2a91aa0ad16e
Set id: e6655ad4-9820-47a5-ab54-1b406293c43f
Version: 1
Effective Time: 20180814
 
EGUARDIAN MEDICARE TECH INC.