OLEA OLIDENTAL- silicon dioxide paste 
AJU PHARM CO., LTD.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Silicon Dioxide 17%

Dental Care

To improve dental health and bad breath

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 physician

Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years ask a dentist or physician

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

Keep out of the reach of children under 6 years of age.

Aluminium Chlorohydroxy Allantoinate
Aminocaproic Acid
Chamomile Extract
Eucalyptus Extract
Sage Extract
Aloe Extract
Grapefruit Seed Extract
Propolis Powder
D-Sorbitol Solution
Concentrated Glycerin
Xantangum
Xylitol
Glucosyl Stevia
Olive Leaf Extract
Hydroxyapatite
Sodium Cocoyl Glutamate
Mint Flavor
Begamot Flavor
Solvent

image description

OLEA OLIDENTAL 
silicon dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70417-002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE170 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCLOXA (UNII: 18B8O9DQA2)  
AMINOCAPROIC ACID (UNII: U6F3787206)  
CHAMOMILE (UNII: FGL3685T2X)  
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
CLARY SAGE (UNII: U3HSK5JC0Q)  
ALOE (UNII: V5VD430YW9)  
CITRUS PARADISI SEED (UNII: 12F08874Y7)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
GLYCERIN (UNII: PDC6A3C0OX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
GLUCOSYL STEVIOL (UNII: TKD5UC898Q)  
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70417-002-021 in 1 CARTON01/17/2017
1NDC:70417-002-01120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/17/2017
Labeler - AJU PHARM CO., LTD. (687982405)
Registrant - AJU PHARM CO., LTD. (687982405)
Establishment
NameAddressID/FEIBusiness Operations
AJU PHARM CO., LTD.687982405manufacture(70417-002)

Revised: 1/2017
Document Id: 469d48d0-49d5-0447-e054-00144ff8d46c
Set id: 5167b6ee-90b7-4066-ae14-e518c7eafe50
Version: 1
Effective Time: 20170121
 
AJU PHARM CO., LTD.