Drugplain

pramosone 10 mg/g

hydrocortisone acetate and pramoxine hydrochloride · OINTMENT · Legacy Pharma USA Inc.

No Recall HistoryCurrently in Shortage
Plain English

pramosone is a ointment containing hydrocortisone acetate and pramoxine hydrochloride at 10 mg/g, taken topical. Manufactured by Legacy Pharma USA Inc..

Key Facts

Brand Name
pramosone
Generic Name
hydrocortisone acetate and pramoxine hydrochloride
NDC Code (Product)
83107-015
Manufacturer
Legacy Pharma USA Inc.
Strength
10 mg/g
Dosage Form
OINTMENT
Route
TOPICAL
Marketing Status
Marketing Start
03/18/2026

Recall History

No Recall History

Side Effects Reported to FDA

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

pruritus14 reports
drug ineffective13 reports
rash13 reports
death10 reports
insomnia9 reports
chronic kidney disease8 reports
dry skin8 reports
dyspnoea8 reports
fatigue7 reports
psoriasis7 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: Topical corticosteroids are generally applied to the affected area as a thin film three 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 Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria

Frequently Asked Questions

What is pramosone used for?

pramosone contains hydrocortisone acetate and pramoxine hydrochloride. It is a ointment taken topical. Consult your doctor for specific uses.

Is pramosone a controlled substance?

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

What is the generic name for pramosone?

The generic name for pramosone is hydrocortisone acetate and pramoxine hydrochloride. There are 11 other brand versions of hydrocortisone acetate and pramoxine hydrochloride.

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

The NDC (National Drug Code) for pramosone 10 mg/g is 83107-015, listed by Legacy Pharma USA Inc..