HYDROCORTISONE ACETATE, IODOQUINOL cream

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ), IODOQUINOL (UNII: 63W7IE88K8) (IODOQUINOL - UNII:63W7IE88K8)

Доступно од:

Bowyn Labs, LLC

INN (Међународно име):

HYDROCORTISONE ACETATE

Састав:

HYDROCORTISONE ACETATE 19 mg in 1 g

Пут администрације:

TOPICAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: “Possibly” Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation. This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

Резиме производа:

This product is supplied in the following size(s): Carton, NDC 52191-352-30, containing 30 sachets (Net Wt. 2 g each). Each sachet is a unit of use - discard after opening. To report a serious adverse event or obtain product information, call 1-855-899-4237. Manufactured for: Bowyn Labs, LLC 13785 Research Blvd., Suite 125 Austin, TX 78750 827515 v3 Rev. 05/2017

Статус ауторизације:

unapproved drug other

Карактеристике производа

HYDROCORTISONE ACETATE, IODOQUINOL- HYDROCORTISONE ACETATE,
IODOQUINOL CREAM
BOWYN LABS, 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 1.9% & IODOQUINOL 1% CREAM WITH ALOE
DESCRIPTION:
Each gram contains 19 mg of hydrocortisone acetate and 10 mg
iodoquinol in a vehicle
consisting of: aloe vera powder, amino methylpropanol 95%, benzyl
alcohol, carbomer,
citric acid anhydrous, D&C yellow #10, FD&C blue #1, glycerin,
glyceryl
polymethacrylate, magnesium aluminum silicate, palmitoyl oligopeptide,
PPG-20 methyl
glucose ether, propylene glycol, purified water and SD Alcohol 40B.
Hydrocortisone acetate is an anti-inflammatory and antipruritic agent.
Chemically,
hydrocortisone acetate is [Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11,
17-dihydroxy-,
(11-ß)-] with the molecular formula (C
H
O
) and is represented by the following
structural formula:
Iodoquinol is an antifungal and antibacterial agent. Chemically,
Iodoquinol is [5,7-diiodo-
8-quinolinol] with the molecular formula (C
H
I
NO) and is represented by the
following structural formula:
CLINICAL PHARMACOLOGY:
Hydrocortisone acetate has anti-inflammatory, antipruritic and
vasoconstrictive
properties. While the mechanism of anti-inflammatory activity is
unclear, there is
evidence to suggest that a recognizable correlation exists between
vasoconstrictor
potency and therapeutic efficacy in humans. Iodoquinol has both
antifungal and
antibacterial properties.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
steroids is
determined by many factors including the vehicle, the integrity of the
epidermal barrier
and the use of occlusive dressings. Hydrocortisone acetate can be
absorbed from
23
32
6
9
5 2
normal intact skin. Inflammation and/or other inflammatory disease
processes in the
skin increase percutaneous absorption. Occlusive dressings
substantially increase the
percutaneou