Drugplain

Hydrocortisone Cream 1% 1 g/100g

Hydrocortisone Cream 1% · CREAM · Front Line Safety

2 Recalls on RecordCurrently in Shortage
Plain English

Hydrocortisone cream 1% is an over-the-counter topical corticosteroid used to reduce inflammation and itching associated with various skin conditions like eczema, psoriasis, and allergic reactions. You apply this cream directly to the affected area of skin as directed on the package.

Key Facts

Brand Name
Hydrocortisone Cream 1%
Generic Name
Hydrocortisone Cream 1%
NDC Code (Product)
58228-6245
Manufacturer
Front Line Safety
Strength
1 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M032
Drug Class
Corticosteroid [EPC]
Marketing Start
01/26/2024

Recall History

2 Recalls on Record
Class II12/07/2018

US Pharmaceuticals Inc.

GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective12 reports
condition aggravated4 reports
pruritus4 reports
dry mouth3 reports
anxiety2 reports
depression2 reports
diarrhoea2 reports
feeling hot2 reports
loss of personal independence in daily activities2 reports
lymphadenopathy2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use(s) For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital, feminine, and anal itching

Dosage & Administration

Directions • 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: Consult a doctor. • When used for anal itching, 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. Children under 12: Consult a doctor before using for anal itching.

Warnings

Warnings For External Use Only If pregnant or breast-feeding Ask a health professional before use Do not use • In the eyes • For diaper rash • For external genital or feminine itching if you have a vaginal discharge • More than the recommended daily dosage unless directed by a doctor • In the rectum by using fingers or any mechanical device or applicator Stop use 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 (do not continue to use this or any other hydrocortisone product for longer than 7 days) • Bleeding occurs due to anal itching Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Frequently Asked Questions

What is Hydrocortisone Cream 1% used for?

Hydrocortisone cream 1% is an over-the-counter topical corticosteroid used to reduce inflammation and itching associated with various skin conditions like eczema, psoriasis, and allergic reactions. You apply this cream directly to the affected area of skin as directed on the package.

Is Hydrocortisone Cream 1% a controlled substance?

Hydrocortisone Cream 1% is not classified as a controlled substance by the DEA.

What is the generic name for Hydrocortisone Cream 1%?

The generic name for Hydrocortisone Cream 1% is Hydrocortisone Cream 1%. There are 4 other brand versions of Hydrocortisone Cream 1%.

What is the NDC code for Hydrocortisone Cream 1% 1 g/100g?

The NDC (National Drug Code) for Hydrocortisone Cream 1% 1 g/100g is 58228-6245, listed by Front Line Safety.

Product NDC

58228-6245

Package NDC

58228-6245-1

Other Hydrocortisone Cream 1% Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)