Ethyl alcohol
Ethyl alcohol is an FDA drug label for the active ingredient ETHYL ALCOHOL manufactured by Strategic Sourcing Services LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260810.
- Generic name
- ETHYL ALCOHOL
- Manufacturer
- Strategic Sourcing Services LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 70677-1220
- Application
- M003
- Label effective
- 20260810
About this product
Ethyl alcohol is an FDA-registered drug product whose active ingredient is ETHYL ALCOHOL. It is labelled by Strategic Sourcing Services LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 70677-1220, application M003, label effective 20260810. 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.
What it is used for
Across FDA labelling, products containing ETHYL ALCOHOL are most often described in connection with: first aid, help prevent, risk infection, minor cuts, scrapes burns. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses first aid to help prevent the risk of infection in: minor cuts scrapes burns
Dosage & Administration
Directions clean the affected area apply a small amount of this product on the area 1 to 3 times daily may be covered with a sterile bandage if bandaged, let dry first
Warnings
Warnings For external use only. If taken internally serious gastric disturbances will result. Flammable keep away from fire or flame, heatm spark, electrical do not use as a fuel source. If exposed to a heat source, vapors may ignite, resulting in severe burns, serious injury, or death.
Adverse Reactions
Adverse event © 2025 Northstar Healthcare LLC Distributed by: McKesson Corp., via SSSL Memphis, TN 38141 Money Back Guarantee www.fosterandthrive.com You may report serious side effects to 833-358-6431 Monday to Friday 9:00am to 7:00pm EST Pat. D675, 101 DSP-TN-21091 DSP-MO-20087
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View labelHow products containing ETHYL ALCOHOL compare
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.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | Diamond Life Cosmetics Trading FZCO | 33 |
| — | — | Ashtel Studios, Inc. | 30 |
| — | — | Amber Glow Cosmetics Limited | 22 |
| — | — | PEACH LAYNE, LLC | 10 |
| — | — | Apollo Health and Beauty Care | 8 |
Recall and safety notices
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.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0004-2026 | Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By: AFCO, 550 Development Avenue, Chambersburg, PA 17210, Toll Free: 800-345-1329, Package Configurations: a) 6x1000mL Case, b) 4x1 Gallon Case, c) 5 Gallon Pail, d) 55 Gallon Drum. | Acuity Specialty Products, Inc. | Class II | Ongoing | 20251015 |
| D-0458-2025 | Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per bottle, Manufactured for Medline Industries, Inc., Three Lakes Drive, Northfield, IL 60693 USA. NDC: 53329-202-08, UPC 8 88277 34945 5 | Consumer Product Partners, LLC | Class II | Ongoing | 20250611 |
| D-0286-2024 | OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, CA, 93436, USA, NDC 59883-500-01, UPC: 3 59883 00000 4. | Den-Mat Holdings, LLC | Class II | Ongoing | 20240207 |
| D-0104-2024 | DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4 | Omega & Delta Co., Inc. | Class II | Ongoing | 20231122 |
| D-0105-2024 | Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9 | Omega & Delta Co., Inc. | Class II | Ongoing | 20231122 |
Frequently asked questions
What is Ethyl alcohol used for?
Uses first aid to help prevent the risk of infection in: minor cuts scrapes burns
Who makes Ethyl alcohol?
Strategic Sourcing Services LLC is the labeler of record for Ethyl alcohol. 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 Ethyl alcohol 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 Ethyl alcohol 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 Ethyl alcohol 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.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.