Pramosone Cream 10 mg/g
hydrocortisone acetate and pramoxine hydrochloride · CREAM · Legacy Pharma USA Inc.
Pramosone Cream is a cream containing hydrocortisone acetate and pramoxine hydrochloride at 10 mg/g, taken topical. Manufactured by Legacy Pharma USA Inc..
Key Facts
- Brand Name
- Pramosone Cream
- Generic Name
- hydrocortisone acetate and pramoxine hydrochloride
- NDC Code (Product)
83107-016- Manufacturer
- Legacy Pharma USA Inc.
- Strength
- 10 mg/g
- Dosage Form
- CREAM
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA085368
- Marketing Start
- 06/27/2025
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 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 Cream used for?
Pramosone Cream contains hydrocortisone acetate and pramoxine hydrochloride. It is a cream taken topical. Consult your doctor for specific uses.
Is Pramosone Cream a controlled substance?
Pramosone Cream is not classified as a controlled substance by the DEA.
What is the generic name for Pramosone Cream?
The generic name for Pramosone Cream is hydrocortisone acetate and pramoxine hydrochloride. There are 10 other brand versions of hydrocortisone acetate and pramoxine hydrochloride.
What is the NDC code for Pramosone Cream 10 mg/g?
The NDC (National Drug Code) for Pramosone Cream 10 mg/g is 83107-016, listed by Legacy Pharma USA Inc..