Drugplain

Hydrocortisone 1% 1 g/100g

Hydrocortisone · CREAM · Chain Drug Marketing Association Inc.

10 Recalls on RecordCurrently in Shortage
Plain English

Hydrocortisone 1% is a cream containing hydrocortisone at 1 g/100g, taken topical. Manufactured by Chain Drug Marketing Association Inc..

Key Facts

Brand Name
Hydrocortisone 1%
Generic Name
Hydrocortisone
NDC Code (Product)
83324-047
Manufacturer
Chain Drug Marketing Association Inc.
Strength
1 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Drug Class
Corticosteroid [EPC]
Marketing Start
03/15/2024

Recall History

10 Recalls on Record
Class III03/18/2026

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II02/10/2017

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

TerminatedVoluntary: Firm initiated
Class II02/10/2017

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

TerminatedVoluntary: Firm initiated
Class III03/18/2026

Island Kinetics, Inc. d.b.a. CoValence Laboratories

Subpotent Drug

TerminatedVoluntary: Firm initiated
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class III11/06/2023

Taro Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone related impurity and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.

TerminatedVoluntary: Firm initiated
Class II08/24/2018

Valeant Pharmaceuticals North America LLC

CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.

TerminatedVoluntary: Firm initiated
Class II02/10/2017

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

TerminatedVoluntary: Firm initiated
Class II02/10/2017

Synergy Rx

Lack of Assurance of Sterility: There are also CGMP Deviations.

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

Side Effects Reported to FDA

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

off label use10,083 reports
drug ineffective8,746 reports
fatigue7,099 reports
condition aggravated6,332 reports
rash6,025 reports
pain5,711 reports
nausea5,403 reports
arthralgia5,046 reports
headache4,956 reports
diarrhoea4,950 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: ● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps ● detergents ● cosmetics ● jewelry ● external feminine genital and anal itching Other uses of this product should be only under the advice and supervision of a doctor

Dosage & Administration

Directions Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor. For External and anal itching: Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with toilet tissue or a soft cloth before application of this product. Children: under 12 years of age with external anal itching: consult a doctor.

Warnings

Warnings For external use only Do not Use: For the treatment of a diaper rash, consult with doctor For external genital itching if you have a vaginal discharge, consult doctor

Frequently Asked Questions

What is Hydrocortisone 1% used for?

Hydrocortisone 1% contains Hydrocortisone. It is a cream taken topical. Consult your doctor for specific uses.

Is Hydrocortisone 1% a controlled substance?

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

What is the generic name for Hydrocortisone 1%?

The generic name for Hydrocortisone 1% is Hydrocortisone. There are 12 other brand versions of Hydrocortisone.

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

The NDC (National Drug Code) for Hydrocortisone 1% 1 g/100g is 83324-047, listed by Chain Drug Marketing Association Inc..