OLEA OLIDENTAL- silicon dioxide paste

Olea Olidental by

Drug Labeling and Warnings

Olea Olidental by is a Otc medication manufactured, distributed, or labeled by AJU PHARM CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Silicon Dioxide 17%

PURPOSE

Dental Care

INDICATIONS & USAGE

To improve dental health and bad breath

DOSAGE & ADMINISTRATION

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

WARNINGS

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 REACH OF CHILDREN

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

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

OLEA OLIDENTAL 
silicon dioxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70417-002
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	170 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70417-002-02	1 in 1 CARTON	01/17/2017
1	NDC: 70417-002-01	120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/17/2017

Labeler - AJU PHARM CO., LTD. (687982405)

Registrant - AJU PHARM CO., LTD. (687982405)

Establishment
Name	Address	ID/FEI	Business Operations
AJU PHARM CO., LTD.		687982405	manufacture(70417-002)