PROCTOZONE-HC 25 mg/g
Hydrocortisone 2.5% · CREAM · Preferred Pharmaceuticals, Inc.
PROCTOZONE-HC is a cream containing hydrocortisone 2.5% at 25 mg/g, taken topical. Manufactured by Preferred Pharmaceuticals, Inc..
Key Facts
- Brand Name
- PROCTOZONE-HC
- Generic Name
- Hydrocortisone 2.5%
- NDC Code (Product)
68788-7091- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Strength
- 25 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA040879
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 02/12/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 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. To report SUSPECTED ADVERSE REACTIONS contact Rising Pharmaceuticals at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is PROCTOZONE-HC used for?
PROCTOZONE-HC contains Hydrocortisone 2.5%. It is a cream taken topical. Consult your doctor for specific uses.
Is PROCTOZONE-HC a controlled substance?
PROCTOZONE-HC is not classified as a controlled substance by the DEA.
What is the generic name for PROCTOZONE-HC?
The generic name for PROCTOZONE-HC is Hydrocortisone 2.5%. There are no other listed brand versions of Hydrocortisone 2.5%.
What is the NDC code for PROCTOZONE-HC 25 mg/g?
The NDC (National Drug Code) for PROCTOZONE-HC 25 mg/g is 68788-7091, listed by Preferred Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)