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Gerigentle

hydrocortisone · Gerigentle is an over-the-counter drug containing hydrocortisone, made by GERI-GENTLE CORPORATION.

Type
Over the counter
Drug class
Not classified
Route
Topical
Manufacturers
1

■ 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 genital, feminine and anal itching.

Drug facts

Generic name
hydrocortisone
Active ingredients
Hydrocortisone Acetate
Dosage forms
Cream
Label holder
GERI-GENTLE CORPORATION
FDA application
M017
Label updated
01/25/2025

Active ingredients

Hydrocortisone Acetate USP (1% w/w)

Purpose

Anti-itch

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 genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor

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 a daily or after a bowel movement
  • After application discard pad
  • Do not flush in toilet

Warnings

For external use only

Do not use

  • In the eyes
  • For diaper rash
  • If you have vaginal discharge
  • More than the recommended dosage

Ask a doctor before use

  • If you are pregnant or breast feeding

Stop use and ask a doctor

  • The condition worsens, or if symptoms persist for more than 7 days or clear up and occur again wihin a few days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Inactive ingredients

Cetostearyl alcohol, chlorocresol, ceteth-20, edetate disodium, liquid paraffin, propylene glycol, purified water, sodium metabisulphite, white soft paraffin

Forms and strengths

From the FDA NDC Directory · 1 product codes

Dosage formStrengthRouteNDCs
Cream10 mg/gtopical1

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

  • GERI-GENTLE CORPORATIONShown hereM017 · Label 01/25/2025 · NDC 69771-192Full label

Related recalls

FDA drug recalls that name this drug or its active ingredient

All drug recalls

Gerigentle: common questions

What is Gerigentle used for?
■ 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 genital, feminine and anal itching.
Is Gerigentle a prescription drug?
No. Gerigentle is sold over the counter (OTC) without a prescription.
Are there other products with the same active ingredient as Gerigentle?
Yes. Other FDA-listed products with the same active ingredients include Hydrocortisone, American Safety and First Aid, Anti-Itch Vulva Cream 1 Hydrocortisone Acetate, Claravie.
Who makes Gerigentle?
GERI-GENTLE CORPORATION lists Gerigentle with the FDA.

Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 01/25/2025 · Label text is shown as published by the manufacturer. Not medical advice