Patient information: uses, side effects, how to take - Hydrocortisone Topical Cream
DOSAGE AND ADMINISTRATION
Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily 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.
HOW SUPPLIED
Hydrocortisone Cream USP, 2.5% is available as follows:
20 g tube (NDC 45802-004-02)
1 oz. (28 g) tube (NDC 45802-004-03)
Hydrocortisone Ointment USP, 2.5% is available as follows:
20 g tube (NDC 45802-014-02)
1 lb. jar (NDC 45802-014-05)
STORAGE
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
Keep out of the reach of children.
Manufactured By Perrigo
Bronx, NY 10457
Distributed By Perrigo
Allegan, MI 49010 · www.perrigo.com
Rev. 08-15
:1F300 RC JX1
Principal Display Panel - Hydrocortisone Cream USP, 2.5% - 28 g
Rx Only
NDC 45802-004-03
Hydrocortisone Cream USP, 2.5%
NET WT 28 g
About this document
Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 085027
· View the label on DailyMed
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The information on this site does not replace the advice of a doctor or pharmacist.
Drug information for Hydrocortisone Topical Cream
| Rx or OTC |
Prescription (Rx)?
- This drug is available only with a prescription from a licensed healthcare provider.
- Rx
|
| Drug class |
Corticosteroid |
| Active ingredient |
Hydrocortisone 25 mg/g
|
| Dosage form |
Cream |
| Route |
Topical |
| Marketing status |
not in the current FDA NDC Directory |
| Company (applicant) |
PADAGIS US |
| FDA approval |
ANDA 085027Abbreviated New Drug Application (ANDA) – generic drug
Approved November 30, 1977
|
| Therapeutic equivalence (TE) code |
ATCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book). |
| Generics |
Alacort, Procto-Med HC, Proctocort Topical, Proctosol-HC, Proctozone HC
with the same TE code
|
| Manufacturers |
17 labelers list this drug on DailyMed |
| Packages (NDC) |
| Package |
|
25 mg/g – 28 g in 1 tube / 1 in 1 carton
NDC 69837-010-01
|
|
Source: FDA drug labeling via NLM DailyMed, data as of November 7, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.
