Hydrocortisone with Aloe

HYDROCORTISONE CREAM 1/2% TOPICAL HUMAN OTC DRUG

Hydrocortisone with Aloe is an FDA drug label for the active ingredient HYDROCORTISONE CREAM 1/2% manufactured by Sun Pharmaceutical Industries, 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 20260816.

Generic name
HYDROCORTISONE CREAM 1/2%
Manufacturer
Sun Pharmaceutical Industries, Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
51672-5335
Application
M017
Label effective
20260816

About this product

Hydrocortisone with Aloe is an FDA-registered drug product whose active ingredient is HYDROCORTISONE CREAM 1/2%. It is labelled by Sun Pharmaceutical Industries, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51672-5335, application M017, label effective 20260816. 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 CREAM 1/2% are most often described in connection with: temporarily relieves, itching associated, minor skin, irritations inflammation, rashes due, eczema insect, bites cosmetics, psoriasis detergents. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredient Hydrocortisone 0.5%

Indications & Usage

Uses temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczema insect bites cosmetics psoriasis detergents soaps poison ivy, oak, sumac jewelry seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should be only 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: 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 in the genital area if you have a vaginal discharge. Consult a doctor. for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with 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.

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-1047-2020 Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactured by: Sun Pharmaceutical Industries Limited Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-829-05 Sun Pharmaceutical Industries, Inc. Class II Terminated 20200325
D-1033-2020 Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-616-50. Sun Pharmaceutical Industries, Inc. Class II Terminated 20200325
D-1032-2020 Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by: Ohm Laboratories Inc., New Brunswick, NJ 08901; Distributed by Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; NDC 63304-615-01. Sun Pharmaceutical Industries, Inc. Class II Terminated 20200325
D-0787-2020 Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL Multiple Dose Vial (NDC 62756-017-40), Rx only, Distributed by: Sun Pharmaceuticals, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceuticals, Industries, Ltd., Gujarat, India Sun Pharmaceutical Industries, Inc. Class II Terminated 20200122
D-0660-2020 Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use blister card, (62756-0522-69), Rx only, Sun Pharma, Cranbury, NJ Sun Pharmaceutical Industries, Inc. Class II Terminated 20200122

Frequently asked questions

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

Who makes Hydrocortisone with Aloe?
Sun Pharmaceutical Industries, Inc. is the labeler of record for Hydrocortisone with Aloe.

What form does Hydrocortisone with Aloe 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 with Aloe 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 Hydrocortisone with Aloe 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.