BENSAL HP- salicylic acid ointment

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

即購入

ダウンロード 製品の特徴 (SPC)
26-01-2023

有効成分:

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

から入手可能:

SMG Pharmaceuticals, LLC

INN(国際名):

Salicylic Acid

構図:

Salicylic Acid 30 mg in 1 g

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

An external treatment for the inflammation and irritation associated with many common forms of dermatitis, including certain eczematoid conditions. These conditions include complications associated with pyodermas. Indicated also in the treatment of insect bites, burns and fungal infections. Bensal HP® is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols. Safety and effectiveness in pediatric patients has not been established.

製品概要:

Store at 20° C to 25° C (68° F to 77° F), excursions permitted between 15° C and 30° C (between 59° F and 86° F). Brief exposure to temperatures up to 40° C (104° F) may be tolerated provided the mean kinetic temperature does not exceed 25° C (77° F); however, such exposure should be minimized.

認証ステータス:

unapproved drug other

製品の特徴

                                BENSAL HP- SALICYLIC ACID OINTMENT
SMG PHARMACEUTICALS, 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._
----------
BENSAL
TOPICAL OINTMENT
Rx Only
PRESCRIBING INFORMATION
DESCRIPTION
Bensal HP
ointment contains 30 mg salicylic acid per gram in a base containing:
Benzoic acid, polyethylene glycol 400, polyethylene glycol 3350 and
oak bark extract
(QRB-7).
CLINICAL PHARMACOLOGY
The mechanism of action of Bensal HP
is not known. While the following animal data
are available, their clinical significance is unknown. It has been
demonstrated that Bensal
HP
significantly reduces methicillin-resistant Staphylococcus aureus
(MRSA) protected
by biofilms in wounds using porcine models. In addition, Bensal HP
stimulates re-
epithelialization of second-degree burns in porcine models.
CLINICAL STUDIES
A randomized, double-blind, placebo-controlled study evaluated the
rate of wound re-
epithelialization. Four partial-thickness wounds (2×2 cm & 0.2 mm
deep) were created
under local anesthesia on the thighs of 13 normal, healthy, male
volunteers with an
electrokeratome. Bensal HP
substantially increased the rate of re-epithelialization by
63% over the vehicle alone (p<0.01) and 77% over untreated control
(p<0.005).
INDICATIONS AND USAGE
An external treatment for the inflammation and irritation associated
with many common
forms of dermatitis, including certain eczematoid conditions. These
conditions include
complications associated with pyodermas. Indicated also in the
treatment of insect bites,
burns and fungal infections.
CONTRAINDICATIONS
Bensal HP
is contraindicated for use in those patients who are hypersensitive to
topical
polyethylene glycols.
HP ®
®
®
®
®
®
®
PRECAUTIONS
For external use only. Not to be used in eyes.
DRUG INTERACTIONS
It is not known if Bensal HP
interacts with other topical medications applied to the
treatment area. The use of Bensal HP
with other topical 
                                
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