Proctocort 10 mg/g

HYDROCORTISONE · CREAM · Salix Pharmaceuticals, Inc

No Recall HistoryCurrently in Shortage

Plain English

Proctocort is a cream containing hydrocortisone at 10 mg/g, taken topical. Manufactured by Salix Pharmaceuticals, Inc.

Key Facts

Brand Name: Proctocort
Generic Name: HYDROCORTISONE
NDC Code (Product): 65649-501
Manufacturer: Salix Pharmaceuticals, Inc
Strength: 10 mg/g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: ANDA080706
Drug Class: Corticosteroid [EPC]
Marketing Start: 06/01/2004

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use10,081 reports

drug ineffective8,743 reports

fatigue7,097 reports

condition aggravated6,328 reports

rash6,020 reports

pain5,710 reports

nausea5,407 reports

arthralgia5,042 reports

headache4,958 reports

diarrhoea4,948 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply 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.

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, and miliaria. To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Proctocort used for?

Proctocort contains HYDROCORTISONE. It is a cream taken topical. Consult your doctor for specific uses.

Is Proctocort a controlled substance?

Proctocort is not classified as a controlled substance by the DEA.

What is the generic name for Proctocort?

The generic name for Proctocort is HYDROCORTISONE. There are 12 other brand versions of HYDROCORTISONE.

What is the NDC code for Proctocort 10 mg/g?

The NDC (National Drug Code) for Proctocort 10 mg/g is 65649-501, listed by Salix Pharmaceuticals, Inc.

Product NDC

65649-501

Package NDC

65649-501-30

Other Hydrocortisone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)