SALICYLIC ACID ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Syntenza Pharmaceuticals LLC

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Salicylic Acid 3% topical ointment is contraindicated for use in those patients who are hypersensitive to topical polyethylene glycols. Safety and effectiveness in pediatric patients has not been established.

Product summary:

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.

Authorization status:

unapproved drug other

Summary of Product characteristics

SALICYLIC ACID- SALICYLIC ACID OINTMENT
SYNTENZA 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._
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SALICYLIC ACID 3% TOPICAL OINTMENT
Rx Only
Prescribing Information
DESCRIPTION
Salicylic Acid 3% topical ointment contains 30 mg salicylic acid per
gram in a base containing: PEG-8,
PEG-75, Benzoic acid and Quercus Alba Bark Extract.
CLINICAL PHARMACOLOGY
The mechanism of action of Salicylic Acid 3% topical ointment is not
known. While the following
animal data are available, their clinical significance is unknown. It
has been demonstrated that Salicylic
Acid 3% topical ointment significantly reduces methicillin-resistant
Staphylococcus aureus (MRSA)
protected by biofilms in wounds using porcine models. In addition,
Salicylic Acid 3% topical ointment
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.
Salicylic Acid 3% topical
ointment 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
Salicylic Acid 3% topical ointment 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 not known if Salicylic Acid 3% topica