Clinical Information
Gen. Code and Des.
7418 hydrocortisone/pramoxine TOPICAL LOTION 2.5 %-1 %
GCN and Des.
84641 hydrocortisone/pramoxine TOPICAL LOTION 2.5 %-1 %
Strength
2.5%
Dose Form
LOTION (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84060800 CORTICOSTEROIDS (SKIN, MUCOUS MEMBRANE)
84080000 ANTIPRURITICS AND LOCAL ANESTHETICS
Active Ingredients
1359 pramoxine HCl 637581
2148 hydrocortisone acetate 50033
Inactive Ingredients
16176 coconut
2537 povidone 9003398
7543 sorbitan esters
FDA NDA Approved
DESCRIPTION:
Analpram HC - ® Lotion 2.5% is a topical preparation containing hydrocortisone acetate 2.5% w/w and pramoxine hydrochloride 1% w/w in a ...
CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions. The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory ...
INDICATIONS AND USAGE:
Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
CONTRAINDICATIONS:
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
PRECAUTIONS:
General: Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and ...
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 ...
OVERDOSAGE:
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See - PRECAUTIONS.)
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 ...
HOW SUPPLIED:
Analpram HC - ® Lotion 2.5% 2 fl oz (NDC 54766-829-04) Storage Conditions: Store at 25°C ...
PRINCIPAL DISPLAY PANEL - NDC: 54766-829-04 - 2 fl oz Bottle Label
