Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 22 November 2019

Indication(s)

INDICATIONS AND USAGE Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Atopic Dermatitis

Atopic Dermatitis

The Atopic Dermatitis Knowledge Centre is an educational resource, intended for healthcare professionals, that provides credible medical information on the epidemiology, pathophysiology and burden of atopic dermatitis, as well as diagnostic techniques, treatment regimens and guideline recommendations.

EADV 2018 Highlights

EADV 2018 Highlights

EADV Congress 2018: Bringing you the latest news and insights from 27th EADV Congress, 12-16 September 2018 Paris, France.

Chronic Spontaneous Urticaria (CSU)

Chronic Spontaneous Urticaria (CSU)

Use our patient case studies to discover how experts diagnose and treat chronic spontaneous urticaria.

+ 7 more

Load more

Related Content

Advisory information

contraindications
CONTRAINDICATIONS Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Adverse reactions
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Apply to the affected area as a thin film from two to four times daily for the 0.025% strength and two or three times daily for the 0.1% and 0.5% strength depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.
Pregnancy and lactation
Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

More information

Category Value
Authorisation number ANDA088042
Agency product number F446C597KA
Orphan designation No
Product NDC 0316-0165,0316-0175,0316-0170
Date Last Revised 10-09-2019
Type HUMAN PRESCRIPTION DRUG
RXCUI 1648999
Storage and handling STORAGE Store at room temperature 20 o - 25 oC (68 o- 77 oF) [see USP Controlled Room Temperature]
Marketing authorisation holder Crown Laboratories