Hydroxym 2 g/100g

HYDROCORTISONE · GEL · PureTek Corporation

No Recall HistoryCurrently in Shortage

Plain English

Hydroxym is a gel containing hydrocortisone at 2 g/100g, taken topical. Manufactured by PureTek Corporation.

Key Facts

Brand Name: Hydroxym
Generic Name: HYDROCORTISONE
NDC Code (Product): 59088-209
Manufacturer: PureTek Corporation
Strength: 2 g/100g
Dosage Form: GEL
Route: TOPICAL
Marketing Status
Drug Class: Corticosteroid [EPC]
Marketing Start: 07/12/2023

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use9,165 reports

drug ineffective7,264 reports

fatigue5,738 reports

condition aggravated5,327 reports

nausea4,844 reports

rash4,749 reports

diarrhoea4,332 reports

pain4,323 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.

Warnings

WARNINGS: For external use only. Not for ophthalmic use. PRECAUTIONS General: Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary- adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings. Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus…

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 Hydroxym used for?

Hydroxym contains HYDROCORTISONE. It is a gel taken topical. Consult your doctor for specific uses.

Is Hydroxym a controlled substance?

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

What is the generic name for Hydroxym?

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

What is the NDC code for Hydroxym 2 g/100g?

The NDC (National Drug Code) for Hydroxym 2 g/100g is 59088-209, listed by PureTek Corporation.

Product NDC

59088-209

Package NDC

59088-209-03

Other Hydrocortisone Brands

See all →

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

Data from openFDA · Public domain (CC0 1.0)