Label: OLEA OLIDENTAL- silicon dioxide paste
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Contains inactivated NDC Code(s)
NDC Code(s): 70417-002-01, 70417-002-02 - Packager: AJU PHARM CO., LTD.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 21, 2017
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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 REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
OLEA OLIDENTAL
silicon dioxide pasteProduct 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)
