Hand Sanitizer Gel

Hand Sanitizer Gel is an FDA-registered drug product whose active ingredient is ETHYL ALCOHOL. It is labelled by Apollo Health and Beauty Care taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 63148-442, application 505G(a)(3), label effective 20260805. It is one of 184 FDA drug label records sharing the active ingredient ETHYL ALCOHOL. 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 ETHYL ALCOHOL are most often described in connection with: personal hand, hygiene help, spread bacteria, washing soap. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Directions - For occasional and personal use. - Rub thoroughly into hands for at least 30 seconds. Allow to dry - Children under 6 should only use the product under adult supervision.

Warnings For external use only. Flammable Keep away from source of heat or fire. Do not use - on infants less than 2 months of age - on open skin wounds - on broken or damaged skin When using this product avoid - contact with eyes. If contact occurs, rinse eyes thoroughly with water. - Do not inhale or ingest. Stop use and ask a doctor if irritation or redness develops and lasts. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

FDA lists 184 drug label records with ETHYL ALCOHOL 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 Hand Sanitizer Gel used for?
Uses for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Who makes Hand Sanitizer Gel?
Apollo Health and Beauty Care is the labeler of record for Hand Sanitizer Gel. 184 FDA label records share the active ingredient ETHYL ALCOHOL, 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 Hand Sanitizer Gel 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 Hand Sanitizer Gel 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 ETHYL ALCOHOL?
Yes. 184 FDA drug label records list ETHYL ALCOHOL 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 Hand Sanitizer Gel 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.