SALICYLIC ACID ointment

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Trifluent Pharma LLC

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. 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

SALICYLIC ACID- SALICYLIC ACID OINTMENT
TRIFLUENT 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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SALICYCLIC ACID 3%
WITH BENZOIC ACID AND OAK BARK EXTRACT
Rx Only
PRESCRIBING INFORMATION
DESCRIPTION
Salicyclic acid with oak bark 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 is salicyclic acid with oak bark is not
known. While the
following animal data are available, their clinical significance is
unknown. It has been
demonstrated that salicyclic acid with oak bark significantly reduces
methicillin- resistant
Staphylococcus aureus (MRSA) protected by biofilms in wounds using
porcine models.
In addition, salicyclic acid with oak bark stimulates
reepithelialization 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
electro keratome. Salicyclic acid with oak bark substantially
increased the rate of re-ep-
ithelialization 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.
CONTRADICTIONS
Salicyclic acid with oak bark is contraindicated for use in those
patients who are
hypersensitive to topical polyethylene glycols.
PRECAUTIONS
For external use only. Not to be used in eyes.
DRUG INTERACTIONS
It is n