Petroleum
Petroleum is an FDA drug label for the active ingredient KEROSENE manufactured by Boiron administered by ORAL. 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 20230711.
- Generic name
- KEROSENE
- Manufacturer
- Boiron
- Product type
- HUMAN OTC DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 0220-3970
- Application
- N/A
- Label effective
- 20230711
About this product
Petroleum is an FDA-registered drug product whose active ingredient is KEROSENE. It is labelled by Boiron taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 0220-3970, label effective 20230711. It is one of 8 FDA drug label records sharing the active ingredient KEROSENE. 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 KEROSENE are most often described in connection with: chapped cracked. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Chapped Or Cracked Fingertips*
Dosage & Administration
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
How products containing KEROSENE compare
FDA lists 8 drug label records with KEROSENE 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 |
|---|---|---|---|
| — | — | Boiron | 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-0803-2018 | Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA | Boiron Inc. | Class III | Terminated | 20180523 |
| D-0285-2026 | Petroleum jelly: a) Vaseline Petroleum Jelly, 1.75, 12CT, UPC: 6001085120946; b) Vaseline Men Cooling Petroleum Jelly, 100ML, 12CT, UPC: 60022141; c) Vaseline Vitamin E, Petroleum Jelly, 100ML, 12CT, UPC: 6001085121028; MEN FRESH PETROLEUM JELLY, 100ML, 12CT, UPC: 60022127; d) Lucky Petroleum Jelly, 6 OZ, 12 PK, UPC: 808829081466;048155903562; e) Lucky Petroleum Jelly, COCOA, 6oz, 12ct, UPC: 808829081572, 048155922150; f) Personal Care, CREAMY PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155908642; g) Personal Care, CREAMY COCOA PETROLEUM JELLY, 4.5oz, 12CT, UPC: 048155922242; h) SOFTEE, PETROLEUM JELLY, 5oz, 12CT, UPC: 096002007208 | GOLD STAR DISTRIBUTION INC | Class II | Ongoing | 20260121 |
| D-0560-2024 | Petroleum Jelly, White Petrolatum USP, NET WT 13 OZ (368g), sold under the following brands - Rite Aid, with UPC 0-11822-51349-4; Kroger, with UPC 0-41260-35275-1; Harris Teeter, with UPC 0-72036-75051-8; CVS, with UPC 0-50428-31702-0 | Consumer Product Partners, LLC | Class II | Terminated | 20240626 |
| D-1402-2022 | SWAN PETROLEUM JELLY 7.5 OZ SKU 910721 BABY LOVE PETROLEUM JELLY 13 OZ SKU 910726 VASELINE PETROLEUM JELLY ORIGINAL 7.5 OZ 2099273 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. | Family Dollar Stores, Llc. | Class II | Ongoing | 20220831 |
| D-0624-2020 | Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 1182298884), b) 2.5 oz tube (UPC 1182298541), Distributed by Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011 | OraLabs, Incorporated | Class II | Terminated | 20191218 |
Frequently asked questions
What is Petroleum used for?
Chapped Or Cracked Fingertips*
Who makes Petroleum?
Boiron is the labeler of record for Petroleum. 8 FDA label records share the active ingredient KEROSENE, 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 Petroleum come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Petroleum 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 KEROSENE?
Yes. 8 FDA drug label records list KEROSENE 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 Petroleum 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.