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PKN Hydrocortisone Acetate Cream

NAFDAC Reg. No. A4-100695 · Drug

Registered with NAFDAC — registration activeAs of 5 November 2026 · synced automatically from official sources.
Product
PKN Hydrocortisone Acetate Cream
NAFDAC number
A4-100695
Active ingredient
Hydrocortisone acetate
Strength
1%
Form
Cream
Pack size
1 x 10 x 15 g (in tubes)
Manufacturer
Not listed
Applicant (holder)
PKN Pharmaceuticals Limited
Approved
21 Dec 2023
Status
Active View on NAFDAC ↗
Registration valid to
20 Dec 2028
WHO alerts
None found
Community reports
None
Times checked
0

RxVerify commentary

  • PKN Hydrocortisone Acetate Cream is on the NAFDAC register with an active registration (A4-100695). A valid number alone does not prove a pack is genuine — counterfeiters copy real numbers, so also check the expiry date, seal and print quality.

Generated automatically from the NAFDAC register, WHO alerts and community data as of today. Not medical advice — always follow your doctor or pharmacist.

What PKN Hydrocortisone Acetate Cream is used for

From the official U.S. FDA label for hydrocortisone acetate, the active ingredient registered with NAFDAC.

What it is used for

Cortifoam ® is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas.

Possible side effects

(listed alphabetically, under each subsection) To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-848-6608 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Allergic reactions: Anaphylactoid reaction, anaphylaxis, angioedema. Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS ), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis. …

Do not use if

Cortifoam ® is contraindicated in patients who are hypersensitive to any components of this product. Local contraindications to the use of intrarectal steroids include obstruction, abscess, perforation, peritonitis, fresh intestinal anastomoses, extensive fistulas and sinus tracts.

Warnings

General Do not insert any part of the aerosol container directly into the anus. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F. Because Cortifoam ® is not expelled, systemic hydrocortisone absorption may be greater from Cortifoam ® than from corticosteroid enema formulations. If there is not evidence of clinical or proctologic improvement within two or three weeks after starting Cortifoam ® therapy, or if the patient's condition worsens, discontinue the drug. Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS ). …

Pregnancy & breastfeeding

Pregnancy Teratogenic Effects Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women. …

General information only — not dosing advice. Always follow the leaflet in your pack and your doctor or pharmacist.

Check your pack of PKN Hydrocortisone Acetate Cream

Add the expiry date printed on your pack for a full Trust Score — or look up uses, side effects and cheaper generics.

3 free checks left today · no signup Official sources: NAFDAC Green Book & recalls · WHO · U.S. FDA · NLM RxNorm

About PKN Hydrocortisone Acetate Cream

What is in PKN Hydrocortisone Acetate Cream?

PKN Hydrocortisone Acetate Cream contains Hydrocortisone acetate (1%), as cream, according to its NAFDAC registration record.

Is PKN Hydrocortisone Acetate Cream registered with NAFDAC?

Yes. PKN Hydrocortisone Acetate Cream is listed on the NAFDAC register under registration number A4-100695, and its registration is active as of 5 November 2026.

Has PKN Hydrocortisone Acetate Cream been flagged as fake or recalled?

No WHO falsified or substandard medical product alert currently matches PKN Hydrocortisone Acetate Cream in our automatically synced alert list.

How can I check that my pack of PKN Hydrocortisone Acetate Cream is genuine?

Run a free authenticity scan with the NAFDAC number A4-100695, your pack's expiry date and batch number to get a Trust Score, compare the pack with the NAFDAC record (ingredient, strength, form, manufacturer), and buy only from licensed pharmacies.

What is PKN Hydrocortisone Acetate Cream used for?

Cortifoam ® is indicated as adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas. (Summarised from the official U.S. FDA label for hydrocortisone acetate. Always follow your doctor or pharmacist.)

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