Drugplain

Hydrocortisone 1% Anti-Itch Cream 1 g/100g

Hydrocortisone · CREAM · DLC Laboratories, Inc.

5 Recalls on RecordCurrently in Shortage
Plain English

Hydrocortisone 1% Anti-Itch Cream is a cream containing hydrocortisone at 1 g/100g, taken topical. Manufactured by DLC Laboratories, Inc..

Key Facts

Brand Name
Hydrocortisone 1% Anti-Itch Cream
Generic Name
Hydrocortisone
NDC Code (Product)
24286-1578
Manufacturer
DLC Laboratories, Inc.
Strength
1 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M017
Drug Class
Corticosteroid [EPC]
Marketing Start
05/15/2024

Recall History

5 Recalls on Record
Class II04/24/2025

KENIL HEALTHCARE PRIVATE LIMITED

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
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

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the temporary relief of itching associated with minor skin irritation, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis for external genital, feminine 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 affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use. Consult a doctor. Adults: for external anal itching: w hen practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of age: for external anal itching, consult a doctor

Warnings

Warnings For external use only for the treatment of diaper rash. Consult a doctor. for external feminine itching if you have a vaginal discharge. Consult a doctor. When using this product avoid contact with the eyes do not use more than directed unless told to do so by a doctor do not put this product into rectum by using fingers or any methanical devices or applicator Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occure again within a few days. Do not begin use of any other hydrocotisone product unless you have consulted a doctor rectal bleeding occurs KEEP OUT OF THE REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Hydrocortisone 1% Anti-Itch Cream used for?

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

Is Hydrocortisone 1% Anti-Itch Cream a controlled substance?

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

What is the generic name for Hydrocortisone 1% Anti-Itch Cream?

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

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

The NDC (National Drug Code) for Hydrocortisone 1% Anti-Itch Cream 1 g/100g is 24286-1578, listed by DLC Laboratories, Inc..