American Safety First Aid
American Safety First Aid is an FDA drug label for the active ingredient LIDOCAINE HCL manufactured by Orazen Inc 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 20260907.
- Generic name
- LIDOCAINE HCL
- Manufacturer
- Orazen Inc
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 71927-012
- Application
- M017
- Label effective
- 20260907
About this product
American Safety First Aid is an FDA-registered drug product whose active ingredient is LIDOCAINE HCL. It is labelled by Orazen Inc taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 71927-012, application M017, label effective 20260907. It is one of 11 FDA drug label records sharing the active ingredient LIDOCAINE HCL. 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 LIDOCAINE HCL are most often described in connection with: temporary relief, pain associated, minor burns. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses for the temporary relief of pain associated with minor burns
Dosage & Administration
Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years: consult a doctor
Warnings
Warnings For external use only
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View labelHow products containing LIDOCAINE HCL compare
FDA lists 11 drug label records with LIDOCAINE HCL 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 |
|---|---|---|---|
| — | — | Prodigy Media Inc | 2 |
| — | — | PureTek Corporation | 2 |
| — | — | AMERISOURCE BERGEN | 1 |
| — | — | Chattem, Inc. | 1 |
| — | — | Clinical Therapeutic Solutions | 1 |
Frequently asked questions
What is American Safety First Aid used for?
Uses for the temporary relief of pain associated with minor burns
Who makes American Safety First Aid?
Orazen Inc is the labeler of record for American Safety First Aid. 11 FDA label records share the active ingredient LIDOCAINE HCL, 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 American Safety First Aid 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 American Safety First Aid 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 LIDOCAINE HCL?
Yes. 11 FDA drug label records list LIDOCAINE HCL 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 American Safety First Aid been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
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.