SALVAX- salicylic acid aerosol, foam

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Exeltis USA Dermatology, LLC

INN (International ime):

SALICYLIC ACID

Sastav:

SALICYLIC ACID 3.88 g in 70 g

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

SALVAX is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae and the various ichthyoses, keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis. SALVAX is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. SALVAX should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients.

Proizvod sažetak:

SALVAX is supplied in a 70 gram or 2.5 ounce aerosolized canister bearing the NDC Number 23710-006-70, a 200 gram or 7.1 ounce aerosolized canister bearing the NDC Number 23710-006-02, and a 10 gram or 0.36 ounce aerosolized canister bearing the NDC Number 23710-006-01. The 10 gram canister is a physician-dispensed sample product. Store at room temperature 15° - 25°C (59° - 77°F). Contains flammable materials. Contents under pressure. Do not puncture or incinerate. Do not expose to temperatures over 120°F (48°C) even when empty.

Status autorizacije:

unapproved drug other

Svojstava lijeka

SALVAX- SALICYLIC ACID AEROSOL, FOAM
EXELTIS USA DERMATOLOGY, 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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SALVAX
salicylic acid, 6%
FOR TOPICAL DERMATOLOGICAL USE ONLY
Hydrating Topical Foam
_(salicylic acid 6% in a water and lipid based foam)_
RX ONLY
DESCRIPTION
SALVAX is applied topically and used in the removal of excessive
keratin in
hyperkeratotic skin disorders. Each gram of SALVAX contains salicylic
acid 6% as the
active ingredient, and the following inactive ingredients:
dimethicone, ethylparaben,
glycerin, methylcellulose, methylparaben, phenoxyethanol, polyoxyl 40
stearate,
polysorbate 20, polysorbate 80, povidone, propylene glycol,
propylparaben, purified
water, sodium citrate, sodium hydroxide, stearic acid, and trolamine
and as propellants
isobutane and propane.
CHEMICAL STRUCTURE
Salicylic acid is the 2-hydroxy derivative of benzoic acid having the
following chemical
structure:
CLINICAL PHARMACOLOGY
Salicylic acid has been shown to produce desquamation of the horny
layer of skin while
not affecting qualitative or quantitative changes in structure of the
viable epidermis. The
mechanism of action has been attributed to dissolution of
intercellular cement
substance. In a study of the percutaneous absorption of salicylic acid
from SALVAX in
four patients with extensive active psoriasis, Taylor and Halprin
showed that peak serum
salicylate levels never exceeded 5 mg/100 ml even though more than 60%
of the applied
salicylic acid was absorbed. Systemic toxic reactions are usually
associated with much
higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred
within 5 hours of
®
the topical application under occlusion. The sites were occluded for
10 hours over the
entire body surface below the neck. Since salicylates are distributed
in the extracellular
space, patients with a contracted extracellular space due to
dehydration or diuretics
h