HYDROCORTISONE ACETATE 2.5% PRAMOXINE HCL 1%- hydrocortisone acetate, pramoxine hcl cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ), PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)

Available from:

KMM Pharmarceuticals, LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

1 oz. (28.4 g) tubes, NDC 52187-533-01 To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: KMM Pharmaceuticals, LLC 1000 N. West Street Suite 1200, #1021 Wilmington, DE 19801 1900290 [00] Rev. 11/2019

Authorization status:

unapproved drug other

Summary of Product characteristics

HYDROCORTISONE ACETATE 2.5% PRAMOXINE HCL 1%- HYDROCORTISONE ACETATE,
PRAMOXINE HCL CREAM
KMM PHARMARCEUTICALS, LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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HYDROCORTISONE ACETATE 2.5% PRAMOXINE HCL 1% CREAM
DESCRIPTION:
This product is a topical preparation containing hydrocortisone
acetate 2.5% w/w, pramoxine
hydrochloride 1% w/w, aloe vera flakes, cetyl alcohol, fragrance,
mineral oil, petrolatum,
phenoxyethanol, polyoxyl 40 stearate, propylene glycol, purifed water,
stearic acid and triethanolamine.
Topical corticosteroids are anti-inflammatory and anti-pruritic
agents. The structural formula, the
chemical name, molecular formula and molecular weight for the active
ingredients are presented below.
hydrocortisone acetate
Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-
C
H
O
; mol. wt.: 404.50
pramoxine hydrochloride
4-(3-(p-butoxyphenoxy)propyl)morpholine hydrochloride
C
H27NO
.HCl; mol. wt.: 329.87
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
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
23
32
6
17
3
efficacies of the topical corticosteroids. There is some evidence to
suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic
efficacy in man.
Pramoxine hydrochloride is a topical anesthetic agent which provides
temporary relief from itching and
pain. It acts by stabilizing the neuronal membrane of nerve endings
with which it comes into contact.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors including the vehicle, the integrity of the epidermal
barrier, and the use of occlusive
dressings.
Topical corticosteroids c