NOVACORT- hydrocortisone acetate and pramoxine hydrochloride gel

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Novum Pharma, LLC

INN (mednarodno ime):

HYDROCORTISONE ACETATE

Sestava:

HYDROCORTISONE ACETATE 20 mg in 1 g

Pot uporabe:

TOPICAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

NDC #69646-704-26 29.0 gram gel tube NDC #69646-704-02 2.0 gram gel sample – not for resale NDC #69646-704-08 10-count carton of 2.0 gram gel sample packs - not for resale NDC #69646-704-01 1.0 gram gel sample – not for resale NDC #69646-704-38 10-count carton of 1.0 gram gel sample packs – not for resale NDC # 69646-704-03: 2.0 gram gel tube sample – not for resale NDC # 69646-704-11: 10-count carton of 2.0 gram gel sample tubes – not for resale Each 1.0 gram gel pack contains multiple doses depending on the surface area treated. Each 2.0 gram gel pack contains multiple doses depending on the surface area treated.

Status dovoljenje:

unapproved drug other

Lastnosti izdelka

NOVACORT- HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE GEL
NOVUM PHARMA, 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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NOVACORT GEL
PRESCRIBING INFORMATION
NOVACORT® GEL
DESCRIPTION
Each gram of NOVACORT contains 2.0% (20 mg) Hydrocortisone Acetate and
1.0% (10
mg) Pramoxine Hydrochloride (HCI). Other Ingredients: Aloe
Polysaccharide, Benzyl
Alcohol, Biopeptide CL, Cetyl Alcohol, Dimethicone, Dimethyl
Isosorbide, Glycerin,
Glyceryl Stearate, Hydroxypropyl Methylcellulose, PEG-100 Stearate,
Phenoxyethanol,
Poloxamer 407, Propylene Glycol, Purified Water,
Stearoxytrimethylsilane, Stearyl
Alcohol, and Witch Hazel Distillate.
HYDROCORTISONE ACETATE
Hydrocortisone Acetate is a topical corticosteroid anti-inflammatory
and anti-pruritic
agent. Chemically, Hydrocortisone Acetate is [Pregn-4-ene-3, 20-dione,
21-(acetyloxy)-
11, 17-dihydroxy-, (11-beta)-C
H
O
] with a molecular weight of 404.50. Chemically,
Hydrocortisone Acetate is represented by the following structural
formula:
PRAMOXINE HYDROCHLORIDE
Pramoxine Hydrochloride (Pramoxine HCl) is a topical anesthetic agent.
Chemically,
Pramoxine Hydrochloride is [4-(3-(p-butoxyphenoxy)propyl) morpholine
Hydrochloride
C
H
NO
• HCI] with a molecular weight of 329.87. Chemically, Pramoxine
Hydrochloride is represented by the following structural formula:
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic, and
vasoconstrictive
23
32
6
17
27
3.
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 efficacies of 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 wh