Drugplain

Procto-Med HC 25 mg/g

HYDROCORTISONE · CREAM · Leading Pharma, LLC

No Recall HistoryCurrently in Shortage
Plain English

Procto-Med Hc is a prescription corticosteroid cream containing hydrocortisone that is applied topically to reduce inflammation and itching associated with hemorrhoids and other rectal conditions. This medication works by decreasing swelling and discomfort in the affected area.

Key Facts

Brand Name
Procto-Med HC
Generic Name
HYDROCORTISONE
NDC Code (Product)
69315-312
Manufacturer
Leading Pharma, LLC
Strength
25 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
ANDA085025
Drug Class
Corticosteroid [EPC]
Marketing Start
02/14/2020

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use9,164 reports
drug ineffective7,264 reports
fatigue5,739 reports
condition aggravated5,323 reports
nausea4,847 reports
rash4,745 reports
diarrhoea4,336 reports
pain4,326 reports
headache4,310 reports
arthralgia4,155 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 dermatosis.

Dosage & Administration

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.

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.

Frequently Asked Questions

What is Procto-Med HC used for?

Procto-Med Hc is a prescription corticosteroid cream containing hydrocortisone that is applied topically to reduce inflammation and itching associated with hemorrhoids and other rectal conditions. This medication works by decreasing swelling and discomfort in the affected area.

Is Procto-Med HC a controlled substance?

Procto-Med HC is not classified as a controlled substance by the DEA.

What is the generic name for Procto-Med HC?

The generic name for Procto-Med HC is HYDROCORTISONE. There are 12 other brand versions of HYDROCORTISONE.

What is the NDC code for Procto-Med HC 25 mg/g?

The NDC (National Drug Code) for Procto-Med HC 25 mg/g is 69315-312, listed by Leading Pharma, LLC.

Product NDC

69315-312

Package NDC

69315-312-28

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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)