Drugplain

Hydrocortisone Cream 25 mg/g

Hydrocortisone Cream · CREAM · Direct_Rx

6 Recalls on RecordCurrently in Shortage
Plain English

Hydrocortisone Cream is a cream containing hydrocortisone cream at 25 mg/g, taken topical. Manufactured by Direct_Rx.

Key Facts

Brand Name
Hydrocortisone Cream
Generic Name
Hydrocortisone Cream
NDC Code (Product)
72189-554
Manufacturer
Direct_Rx
Strength
25 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA085025
Drug Class
Corticosteroid [EPC]
Marketing Start
05/30/2024

Recall History

6 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 II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

TerminatedVoluntary: Firm initiated
Class II07/11/2019

US Pharmaceuticals Inc.

CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

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

off label use9,172 reports
drug ineffective7,292 reports
fatigue5,751 reports
condition aggravated5,332 reports
nausea4,874 reports
rash4,781 reports
diarrhoea4,352 reports
pain4,334 reports
headache4,319 reports
dyspnoea4,161 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 used for?

Hydrocortisone Cream contains Hydrocortisone Cream. It is a cream taken topical. Consult your doctor for specific uses.

Is Hydrocortisone Cream a controlled substance?

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

What is the generic name for Hydrocortisone Cream?

The generic name for Hydrocortisone Cream is Hydrocortisone Cream. There are 10 other brand versions of Hydrocortisone Cream.

What is the NDC code for Hydrocortisone Cream 25 mg/g?

The NDC (National Drug Code) for Hydrocortisone Cream 25 mg/g is 72189-554, listed by Direct_Rx.