Is Sion Biotext Medical Ltd FDA approved?

Sion Biotext Medical Ltd holds 1 FDA-registered establishment in Israel. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Sion Biotext Medical Ltd's drugs manufactured?

The FDA register lists Sderot. Registered operations: finished drug manufacture.

What drugs does Sion Biotext Medical Ltd make?

14 products are listed under Sion Biotext Medical Ltd in the openFDA NDC Directory, most often as swab; ointment; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Sion Biotext Medical Ltd

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 14
Labeller names: 2
Live patents: 0
Countries: 1
Base: Israel

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Sion Biotext Medical Ltd	3 Haeshel, Sderot, - 8710203, Israel (ISR)	Finished drug manufacture	3006118668532775194

Catalogue

Drug listings by form and route

14 active NDC listings: 14 human otc drug. By marketing category: OTC MONOGRAPH DRUG 14.

Dosage form	NDCs
swab	6
ointment	3
solution	2
cream	1
gel	1
jelly	1

Route	NDCs
topical	13
oral	1

Labeller name on the listing	NDCs
sion biotext medical ltd	13
sion biotext medical ltd.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Alcohol	Alcohol	swab, topical	68786-300OTC MONOGRAPH DRUG
Lemon	Glycerin	swab, oral	68786-160OTC MONOGRAPH DRUG
Povidone Iodine	POVIDONE-IODINE	swab, topical	68786-130OTC MONOGRAPH DRUG
Povidone Iodine	POVIDONE-IODINE	swab, topical	68786-140OTC MONOGRAPH DRUG
Povidone Iodine Gel Swabstick	Povidone Iodine Gel Swabstick	gel, topical	68786-418OTC MONOGRAPH DRUG
Povidone Iodine Prep	Povidone Iodine	solution, topical	68786-010OTC MONOGRAPH DRUG
Povidone Iodine Prep	Povidone Iodine	solution, topical	68786-132OTC MONOGRAPH DRUG
Sion Biotext Bacitracin Zinc	Bacitracin Zinc	ointment, topical	68786-500OTC MONOGRAPH DRUG
SionBiotext Hydrocortisone	Hydrocortisone Acetate 1%	cream, topical	68786-001OTC MONOGRAPH DRUG
SionBiotext Triple Antibiotic	Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate	ointment, topical	68786-400OTC MONOGRAPH DRUG
Vitamin A D	WHITE PETROLATUM	ointment, topical	68786-213OTC MONOGRAPH DRUG
WHITE PETROLATUM	PETROLATUM	jelly, topical	68786-211OTC MONOGRAPH DRUG
alcohol	alcohol	swab, topical	68786-120OTC MONOGRAPH DRUG
alcohol	alcohol	swab, topical	68786-122OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Sion Biotext Medical Ltd FDA approved?: Sion Biotext Medical Ltd holds 1 FDA-registered establishment in Israel. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Sion Biotext Medical Ltd's drugs manufactured?: The FDA register lists Sderot. Registered operations: finished drug manufacture.
What drugs does Sion Biotext Medical Ltd make?: 14 products are listed under Sion Biotext Medical Ltd in the openFDA NDC Directory, most often as swab; ointment; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.