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MediBalm

hydrocortisone · MediBalm is a corticosteroid (over-the-counter) containing hydrocortisone, made by BalmRx, LLC.

Type
Over the counter
Drug class
Corticosteroid
Route
Topical
Manufacturers
1

For the temporary relief of itching associated with minor skin irritations and rashes due to: Eczema Cosmetics Psoriasis Seborrheic Dermatitis Other uses of this product should be only under the advice and supervision of a physician.

Drug facts

Generic name
hydrocortisone
Active ingredients
Hydrocortisone
Drug class
Corticosteroid
How it works
Corticosteroid Hormone Receptor Agonists
Dosage forms
Ointment
Label holder
BalmRx, LLC
FDA application
M017
Label updated
06/26/2025

Active ingredients

PURPOSE Hydrocortisone 1.0%...........Anti-Itch

Purpose

ACTIVE INGREDIENT PURPOSE Hydrocortisone 1.0%...........Anti-Itch

Uses

For the temporary relief of itching associated with minor skin irritations and rashes due to: Eczema Cosmetics Psoriasis Seborrheic Dermatitis Other uses of this product should be only under the advice and supervision of a physician.

Directions

D IRECTIONS Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily for up to 7 days. Children under 2 years of age: do not use, consult a physician

Warnings

For external use only. Avoid contact with eyes.

Do not use

For the treatment of diaper rash. Consult a doctor.

Stop use and ask a doctor

And ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Any use of this product other than those listed above should be under the advice and supervision of a doctor.

Keep out of reach of children

Keep out of reach of children

Other information

Store at 59-80 F (15-30 C). Protect from freezing.

Inactive ingredients

Coconut oil, shea butter, cera microcristallina, tocopherol, phenoxyethanol

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Ointment1 g/100gtopical1

Side effect reports to FDA

FDA Adverse Event Reporting System (FAERS), 88,291 reports that list hydrocortisone, data through 07/30/2026

Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.

Most often reported reactions

  • Off label use11,929
  • Drug ineffective10,802
  • Fatigue9,272
  • Pain7,365
  • Nausea7,039
  • Condition aggravated6,989
  • Arthralgia6,954
  • Headache6,492
  • Rash6,469
  • Diarrhea6,383

To report a side effect, use FDA MedWatch.

Manufacturers and labels

1 FDA label

  • BalmRx, LLCShown hereM017 · Label 06/26/2025 · NDC 85529-204Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

MediBalm: common questions

What is MediBalm used for?
For the temporary relief of itching associated with minor skin irritations and rashes due to: Eczema Cosmetics Psoriasis Seborrheic Dermatitis Other uses of this product should be only under the advice and supervision of a physician.
Is MediBalm a prescription drug?
No. MediBalm is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as MediBalm?
Yes. Other FDA-listed products with the same active ingredients include Anti Itch, hydrocortisone 1, Hydrocortisone with Aloe, Hydrocortisone.
Who makes MediBalm?
BalmRx, LLC lists MediBalm with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 06/26/2025 · Label text is shown as published by the manufacturer. Not medical advice