hydrocortisone 1

HYDROCORTISONE TOPICAL HUMAN OTC DRUG

hydrocortisone 1 is an FDA drug label for the active ingredient HYDROCORTISONE manufactured by Kroger Company 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 20260819.

Generic name
HYDROCORTISONE
Manufacturer
Kroger Company
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
30142-369
Application
M017
Label effective
20260819

About this product

hydrocortisone 1 is an FDA-registered drug product whose active ingredient is HYDROCORTISONE. It is labelled by Kroger Company taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 30142-369, application M017, label effective 20260819. 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, irritations inflammation, rashes due, eczema psoriasis, poison ivy, oak sumac. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Hydrocortisone 1%

Indications & Usage

Uses • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • seborrheic dermatitis • cosmetics • soaps • temporarily relieves external anal and genital itching • other uses of this product should only be under the advice and supervision of a doctor

Dosage & Administration

Directions • for itching of skin irritation, inflammation, and rashes: • 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: do not use, ask a doctor • for external anal and genital itching, adults: • when practical, clean the affected area with mild soap and warm water and rinse thoroughly • gently dry by patting or blotting with toilet tissue or a soft cloth before applying • apply to affected area not more than 3 to 4 times daily • children under 12 years of age: ask a doctor

Warnings

Warnings For external use only Do not use • for the treatment of diaper rash. Ask a doctor. • in the genital area if you have a vaginal discharge. Ask a doctor. When using this product • avoid contact with the eyes • do not use more than directed unless told to do so by a doctor • do not put directly into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor • rectal bleeding occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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HYDROCORTISONE

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Alkindi Sprinkle

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Aloe Cort

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Ana Cool Rapid Soothing Cooling Formula

Ana-Cool, LLC View label

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Anti-Itch Regular Strength

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How 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 formProductsManufacturerProducts
— — 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.

RecallProductFirmClassStatusReported
D-0480-2026 Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle, Distributed By: glo Skin Beauty, Denver, CO 80216. NDC 66915-531-12; 66915-531-13 Island Kinetics, Inc. d.b.a. CoValence Laboratories Class III Terminated 20260422
D-0481-2026 Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04 Island Kinetics, Inc. d.b.a. CoValence Laboratories Class III Terminated 20260422
D-0482-2026 Essential Calming Skin Gel, hydrocortisone 1%, 120mL/4oz net wt. (113g) per jar, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM, NDC 66915-531-05 Island Kinetics, Inc. d.b.a. CoValence Laboratories Class III Terminated 20260422
D-0428-2025 Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2. KENIL HEALTHCARE PRIVATE LIMITED Class II Terminated 20250528
D-0633-2024 Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-3007-01 Taro Pharmaceuticals U.S.A., Inc. Class III Completed 20240821

Frequently asked questions

What is hydrocortisone 1 used for?
Uses • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: • eczema • psoriasis • poison ivy, oak, sumac • insect bites • detergents • jewelry • seborrheic dermatitis • cosmetics • soaps • temporarily relieves external anal and genital itching • other uses of this product should only be under the advice and supervision of a doctor

Who makes hydrocortisone 1?
Kroger Company is the labeler of record for hydrocortisone 1. 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 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 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 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.