Fire Out
Fire Out is an FDA drug label for the active ingredient BENZOCAINE AND MENTHOL manufactured by Randob Ltd. 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 20190412.
- Generic name
- BENZOCAINE AND MENTHOL
- Manufacturer
- Randob Ltd.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 52412-300
- Application
- part348
- Label effective
- 20190412
About this product
Fire Out is an FDA-registered drug product whose active ingredient is BENZOCAINE AND MENTHOL. It is labelled by Randob Ltd. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 52412-300, application part348, label effective 20190412. It is one of 5 FDA drug label records sharing the active ingredient BENZOCAINE AND MENTHOL. 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 BENZOCAINE AND MENTHOL are most often described in connection with: temporarily relieves, itching fire, ant bites, stings insect, minor skin. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses ▪ Temporarily relieves pain and itching of fire ant bites and stings, insect bites and stings, and minor skin irritation.
Dosage & Administration
Directions Children under 2 yrs. ▪ Do not use ▪ Consult doctor Adults and children 2 yrs. and older ▪ Clean area ▪ Apply to affected area as needed not more than 3 to 4 times a day.
Warnings
Warnings ▪ For external use only ▪ Do not apply over large areas of the body ▪ Avoid contact with eyes, mouth, and mucous membranes
More products with the same ingredient
BENZOCAINE AND MENTHOLCepacol Extra Strength Sore Throat cherry
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View labelSting-Kill
View labelHow products containing BENZOCAINE AND MENTHOL compare
FDA lists 5 drug label records with BENZOCAINE AND MENTHOL 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 |
|---|---|---|---|
| — | — | Reckitt Benckiser LLC | 2 |
| — | — | Church & Dwight Co., Inc. | 1 |
| — | — | RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH | 1 |
| — | — | Randob Ltd. | 1 |
| — | — | — | — |
Frequently asked questions
What is Fire Out used for?
Uses ▪ Temporarily relieves pain and itching of fire ant bites and stings, insect bites and stings, and minor skin irritation.
Who makes Fire Out?
Randob Ltd. is the labeler of record for Fire Out. 5 FDA label records share the active ingredient BENZOCAINE AND MENTHOL, 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 Fire Out 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 Fire Out 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 BENZOCAINE AND MENTHOL?
Yes. 5 FDA drug label records list BENZOCAINE AND MENTHOL 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 Fire Out 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.