FixMySkin Healing Balm Unflavored
FixMySkin Healing Balm Unflavored is an FDA drug label for the active ingredient HYDROCORTISONE manufactured by Lovely Skin, 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 20260423.
- Generic name
- HYDROCORTISONE
- Manufacturer
- Lovely Skin, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 76314-003
- Application
- M017
- Label effective
- 20260423
About this product
FixMySkin Healing Balm Unflavored is an FDA-registered drug product whose active ingredient is HYDROCORTISONE. It is labelled by Lovely Skin, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 76314-003, application M017, label effective 20260423. It is one of 81 FDA drug label records sharing the active ingredient HYDROCORTISONE. 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 HYDROCORTISONE are most often described in connection with: temporary relief, itching associated, minor skin, irritations inflammation, rashes due, eczema psoriasis, seborrheic dermatitis, insect bites. 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 itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, seborrheic dermatitis, insect bites, poison oak, or poison sumac, soaps, detergents, cosmetics, and jewelry, and for external genital and feminine itching, and external analgesic. Other uses of this product should only be under the advice and supervision of a doctor.
Dosage & Administration
Directions For itching associated with skin irritation, inflammation and rashes: Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use - consult a doctor.
Warnings
Warnings For external use only. Avoid contact with eyes.
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View labelHow products containing HYDROCORTISONE compare
FDA lists 81 drug label records with HYDROCORTISONE 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 |
|---|---|---|---|
| — | — | Preferred Pharmaceuticals Inc. | 5 |
| — | — | Bryant Ranch Prepack | 4 |
| — | — | CVS Pharmacy | 3 |
| — | — | Amazon.com Services LLC | 2 |
| — | — | Ana-Cool, LLC | 2 |
Frequently asked questions
What is FixMySkin Healing Balm Unflavored used for?
Uses For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, psoriasis, seborrheic dermatitis, insect bites, poison oak, or poison sumac, soaps, detergents, cosmetics, and jewelry, and for external genital and feminine itching, and external analgesic. Other uses of this product should only be under the advice and supervision of a doctor.
Who makes FixMySkin Healing Balm Unflavored?
Lovely Skin, Inc. is the labeler of record for FixMySkin Healing Balm Unflavored. 81 FDA label records share the active ingredient HYDROCORTISONE, 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 FixMySkin Healing Balm Unflavored 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 FixMySkin Healing Balm Unflavored 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 HYDROCORTISONE?
Yes. 81 FDA drug label records list HYDROCORTISONE 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 FixMySkin Healing Balm Unflavored 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.