Hydrocortisone 1% Anti-ItchCream
Hydrocortisone 1% Anti-ItchCream is an FDA drug label for the active ingredient HYDROCORTISONE manufactured by Acme United Corporation 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 20260613.
- Generic name
- HYDROCORTISONE
- Manufacturer
- Acme United Corporation
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 0924-5634
- Application
- M017
- Label effective
- 20260613
About this product
Hydrocortisone 1% Anti-ItchCream is an FDA-registered drug product whose active ingredient is HYDROCORTISONE. It is labelled by Acme United Corporation taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 0924-5634, application M017, label effective 20260613. 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: temporarily relieves, itching associated, minor skin, supervision doctor. 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 itching associated with minor skin irritations and rashes other uses of this product should only be under the advice and supervision of a doctor
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 of age: consult a doctor.
Warnings
Warnings For external use only Avoid Contact with the eyes Do not use If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, Stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor .Do not use for the treatment of diaper rash. Consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
More products with the same ingredient
HYDROCORTISONEAEROSOOTHE
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View labelAnti itch
View labelAnti-Itch Regular Strength
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 |
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-0376-2026 | Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04. | ACME UNITED CORPORATION | Class II | Ongoing | 20260311 |
| D-0361-2026 | First Aid Only BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%), 5x7, bulk, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC, 27801 Made in USA, NDC 0924-7116-00. | ACME UNITED CORPORATION | Class II | Ongoing | 20260311 |
| D-0368-2026 | Wipes Plus, Hand Sanitizing Alcohol Free BZK Wipes (Benzalkonium Chloride 0.13%), Manufactured for: CFS Brands DBA WipesPlus, 4711 E. Heiner Rd. Oklahoma City, OK 73331, NDC 67151-333-01. | ACME UNITED CORPORATION | Class II | Ongoing | 20260311 |
| D-0359-2026 | First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 50 Wipes, NDC 0924-7116-03. | ACME UNITED CORPORATION | Class II | Ongoing | 20260311 |
| D-0366-2026 | Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01. | ACME UNITED CORPORATION | Class II | Ongoing | 20260311 |
Frequently asked questions
What is Hydrocortisone 1% Anti-ItchCream used for?
Uses temporarily relieves itching associated with minor skin irritations and rashes other uses of this product should only be under the advice and supervision of a doctor
Who makes Hydrocortisone 1% Anti-ItchCream?
Acme United Corporation is the labeler of record for Hydrocortisone 1% Anti-ItchCream. 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 Hydrocortisone 1% Anti-ItchCream 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 Hydrocortisone 1% Anti-ItchCream 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 Hydrocortisone 1% Anti-ItchCream 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.