procure

HYDROCORTISONE ACETATE TOPICAL HUMAN OTC DRUG

procure is an FDA drug label for the active ingredient HYDROCORTISONE ACETATE manufactured by TWIN MED, LLC 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 20260803.

Generic name
HYDROCORTISONE ACETATE
Manufacturer
TWIN MED, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
55681-224
Application
M017
Label effective
20260803

About this product

procure is an FDA-registered drug product whose active ingredient is HYDROCORTISONE ACETATE. It is labelled by TWIN MED, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 55681-224, application M017, label effective 20260803. It is one of 15 FDA drug label records sharing the active ingredient HYDROCORTISONE ACETATE. 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 ACETATE are most often described in connection with: temporary relief, minor skin, irritations itching, rashes due, eczema insect, bites poison, sumac soaps, detergents cosmetics. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active Ingredient (per gram) Hydrocortisone Acetate, USP (1% w/w)

Indications & Usage

Uses For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external gential, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.

Dosage & Administration

Directions Adults and children over 2 years of age Apply evenly to affected area no more than 3 to 4 times daily Children under 2 years of age Do not use, consult a doctor Adults- When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly Gently dry, patting or blotting with bathroom tissue or soft cloth before applying apply externally to the area up to 6 times daily or after bowel movment After application, discard pad. Do not flush in toilet.

Warnings

Warnings FOR EXTERNAL USE ONLY. Do not use In the eyes for diaper rash if you have vaginal discharge more than recommended dosage. Ask a doctor before use if you are pregnant or breast feeding Stop use and ask a doctor if the condition worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

More products with the same ingredient

HYDROCORTISONE ACETATE

ANUCORT-HC

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A-S Medication Solutions View label

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How products containing HYDROCORTISONE ACETATE compare

FDA lists 15 drug label records with HYDROCORTISONE ACETATE 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
— — Cosette Pharmaceuticals, Inc. 2
— — A-S Medication Solutions 1
— — AARNA USA INC. 1
— — APNAR PHARMA LP 1
— — Bentlin Products LLC 1

Recall and safety notices

2 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-1244-2022 Hydrogen Peroxide Topical Solution USP, 3%, 16 FL OZ (1 PT) 473 mL bottle, packaged as a) Signature Care NDC 21130-871-43 UPC 3 21130-78060 1 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; b) Solimo UPC 8 42379 14781 4 Distributed By: Amazon.com Services, Inc. Seattle, WA 98109; c) QC Quality Choice UPC 6 35515 99466 9 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd, Novi, MI; d) CVS Health UPC 0 50428 37591 4 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; e) Careone UPC 3 41520 31311 0 Distributed By: Foodhold U.S.A., LLC Landover, MD 20785; f) Market Basket UPC 0 49705 75280 7 Distributed By Demoulas Super Markets, Inc. 875 East Street, Tewksbury, MA 01876; g) Rexall UPC 0 72785 13848 3 Distributed By Old East Main Co. 100 Mission Ridge, Goodlettsville, TN 37072; h) HEB UPC 9 41220 25111 7 Distributed By: HEB San Antonio, TX 78204; i) Core Values UPC 0 79068 00707 8 Distributed by Liberty Procurement Co., Inc. Union, NJ 07083; j) Swan NDC 0869-0871-43 UPC 3 08694 70610 0 Distributed by Vi-Jon One Swan Drive, Smyrna, TN 37167; k) Cariba Care UPC 6 46702 05602 2 Distributed by: Cariba International P.O. Box 1208. Safety Harbor, Florida 34695; l) Kroger UPC 0 11110 79460 4 Distributed By The Kroger Co., Cincinnati, Ohio 45202; m) CVP Health UPC 7 61706 16314 6 Distributed By Salado Sales, Inc. Temple, TX 76503; n) Medline NDC 53329-981-06 UPC 0 80196 74870 2 Made in US with US and foreign components for Medline Industries, Inc., Northfield, IL 60093; o) Exchange Select UPC 6 14299 39968 6 Manufactured For Your Military Exchanges By: Vi-Jon 8515 Page Avenue, St. Louis, MO 63114; p) Premier Value UPC 8 40986 01021 7 Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue Wayne, PA 19087; q) Publix UPC 0 41415 00973 8 Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway Lakeland, FL 33811; r) Being Well UPC 0 51933 13950 3 Distributed By: Moran Foods, LLC St. Ann, MO 63074; s) Medicare NPN 80016265 UPC 8 39748 00017 7 Manufactured by/Fabrique par: Vi-Jon Inc., Smyna, TN 37167; t) Swan NPN 80035214 UPC 0 72785 11239 1 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; u) Equate NPN 80036214 UPC 6 28915 16613 3 Manufactured By: Vi-Jon, Inc. St. Louis, MO 63114; v) Iris UPC 61504-871-43 UPC 0 41512 12940 7 Distributed By: Amerifoods Trading Co. P.O. Box 512377, Los Angeles, CA 90051-0377; w) Equaline NDC 41163-871-43 UPC 0 41163 25134 2 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA; x) TopCare health UPC 0 36800 26711 4 Distributed By TopCo Associates LLC Elk Grove Village, IL 60007; y) Best Choice UPC 0 70038 20055 0 Distributed By: Valu Merchandisers, Co. 6000 Kansas Ave. Kansas City, KS 66106; z) Walgreens NDC 0363-0871-43 UPC 3 11917 20771 1 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015; aa) Equate NDC 49035-871-43 UPC 6 81131 11871 2 Distributed By: Walmart, Inc., Bentonville, AR 72716 Vi-Jon, LLC Class II Terminated 20220727
D-1582-2020 LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, Distributed by: Procurement Services, LLC Nashville, TN 37215, Product of Mexico. NDC 74882-007-02 Real Clean Distribuciones SA de CV Class II Terminated 20200923

Frequently asked questions

What is procure used for?
Uses For temporary relief of minor skin irritations, itching and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, and for external gential, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.

Who makes procure?
TWIN MED, LLC is the labeler of record for procure. 15 FDA label records share the active ingredient HYDROCORTISONE ACETATE, 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 procure 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 procure 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 ACETATE?
Yes. 15 FDA drug label records list HYDROCORTISONE ACETATE 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 procure been recalled?
2 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.