Neomycin Sulfate

Neomycin Sulfate is an FDA-registered drug product whose active ingredient is NEOMYCIN SULFATE. It is labelled by Shaanxi Shuvita Biotech Co., Ltd taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87879-003, application 505G(a)(3), label effective 20260722. It is one of 3 FDA drug label records sharing the active ingredient NEOMYCIN SULFATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing NEOMYCIN SULFATE are most often described in connection with: pharmaceutical intermediate, raw material, formulation compounding, lab research, pharmacy manufacturing. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Use For industrial use: Pharmaceutical intermediate raw material for formulation compounding, lab research & pharmacy manufacturing.

Directions Industrial Storage & Handling Directions: - Warehouse bulk storage: Seal drums tightly, store at 20–25°C (68-77°F) - Avoid direct sunlight, excessive moisture & extreme temperature fluctuation - Handling: Transfer under low-dust ventilation hood only

Warnings When handling this product ■ May cause skin & eye irritation; wear full PPE (gloves, goggles, respirator) ■ Avoid direct skin contact, inhalation of dust ■ Do not ingest; keep separate from food, drinks ■ Keep away from ignition sources, strong oxidizers ■ Restless/irritability may occur with improper exposure, especially for personnel without chemical handling training If pregnant/breastfeeding, consult industrial hygiene specialist before handling. Keep out of reach of children & untrained personnel. In case of accidental ingestion/skin absorption/eye contact, flush affected area with plenty of clean water and seek emergency medical help immediately.

FDA lists 3 drug label records with NEOMYCIN SULFATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Neomycin Sulfate used for?
Use For industrial use: Pharmaceutical intermediate raw material for formulation compounding, lab research & pharmacy manufacturing.

Who makes Neomycin Sulfate?
Shaanxi Shuvita Biotech Co., Ltd is the labeler of record for Neomycin Sulfate. 3 FDA label records share the active ingredient NEOMYCIN SULFATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Neomycin Sulfate come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Neomycin Sulfate prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing NEOMYCIN SULFATE?
Yes. 3 FDA drug label records list NEOMYCIN SULFATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Neomycin Sulfate been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.