Barrier Balm
Barrier Balm is an FDA drug label for the active ingredient BARRIER BALM manufactured by Autumn Harp, 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 20230801.
- Generic name
- BARRIER BALM
- Manufacturer
- Autumn Harp, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 51514-0363
- Application
- M016
- Label effective
- 20230801
About this product
Barrier Balm is an FDA-registered drug product whose active ingredient is BARRIER BALM. It is labelled by Autumn Harp, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51514-0363, application M016, label effective 20230801. 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 BARRIER BALM are most often described in connection with: directions apply. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Directions Apply as needed
Dosage & Administration
Apply as needed
Warnings
Warnings For external use only Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away Do not use on deep or puncture wounds, animal bites, serious burns When using this product do not get into eyes Stop use and ask doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days
Frequently asked questions
What is Barrier Balm used for?
Directions Apply as needed
Who makes Barrier Balm?
Autumn Harp, Inc. is the labeler of record for Barrier Balm.
What form does Barrier Balm 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 Barrier Balm 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.
Has Barrier Balm 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.