ALCORTIN A- hydrocortisone acetate, aloe vera leaf and iodoquinol gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ), ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X), Iodoquinol (UNII: 63W7IE88K8) (Iodoquinol - UNII:63W7IE88K8)

Available from:

Primus Pharmaceuticals

INN (International Name):

HYDROCORTISONE ACETATE

Composition:

HYDROCORTISONE ACETATE 20 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Alcortin A is contraindicated in those patients with a history of hypersensitivity to hydrocortisone acetate, iodoquinol, aloe vera, glycine, histidine, lysine, palmitic acid or any other components of the preparation.

Product summary:

48.0 gram carton of 24-count of 2.0 gram gel individual packs NDC #68040-705-13 2.0 gram gel individual pack NDC # 68040-705-02 10 count carton of 2.0 gram gel sample packs - not for resale NDC # 68040-705-08 Each 2.0 gram gel pack contains multiple doses depending on the surface area treated. Store at room temperature 15º-30ºC (59º-86ºF). Keep tightly closed.

Authorization status:

unapproved drug other

Summary of Product characteristics

ALCORTIN A- HYDROCORTISONE ACETATE, ALOE VERA LEAF AND IODOQUINOL GEL
PRIMUS PHARMACEUTICALS
_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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ALCORTIN® A GEL
PRESCRIBING INFORMATION
DESCRIPTION
Each gram of Alcortin® A contains 2.0% (20 mg) Hydrocortisone Acetate
and 1.0% (10 mg)
Iodoquinol. Also contains 1.0% (10 mg) Aloe polysaccharide . Other
ingredients: Purified Water,
Carbopol, Magnesium Aluminum Silicate, PPG-20 Methyl Glucose Ether,
Aminomethyl Propanol,
Propylene Glycol, Glycerine, Benzyl Alcohol, SD Alcohol 40 B,
Biopeptide, Hydrochloric Acid,
FD&C Blue # 1 and FD&C Yellow # 10.
1
IODOQUINOL
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:
HYDROCORTISONE ACETATE
Hydrocortisone acetate is an anti-inflammatory and antipruritic agent.
Chemically, hydrocortisone
acetate is [Pregn-4-ene-3, 20-dione, 11, 17, 21- trihydroxy-, (11β)-]
with the molecular formula
(C
H O ) and is represented by the following structural formula:
CLINICAL PHARMACOLOGY
1
U.S. Patents
#6,4 36,679; #6,271,214 ; #6,133,4 4 0; #5,708,038; patent pending
9
5 2
21
30
5
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 normal intact skin. Inflammation and/or
other inflammatory disease
processes in the skin i