RAYASAL- salicylic acid 5.9% cream

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Raya Pharmaceuticals LLC

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

RAYASAL should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredients. For dermatologic Use RAYASAL 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. For Podiatric Use RAYASAL is a topical aid in removing excessive keratin on dorsal and plantar hyperkeratotic lesions.

Vörulýsing:

RAYASAL Salicylic Acid 5.9% Gel is supplied in a 95-gram AIRLESS pump bearing the NDC Number 382098-009-95 Store at a controlled room temperature of 15° - 30°C (59° - 86°F). [See USP “Controlled Room Temperature”]

Leyfisstaða:

unapproved drug other

Vara einkenni

RAYASAL- SALICYLIC ACID 5.9% CREAM
RAYA 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._
----------
RAYASAL
salicylic acid, 5.9% Cream
Rx Only
For Topical Dermatological Use Only, not for ophthalmic, oral, or
intravaginal use.
RAYASAL is applied topically and used to remove excessive keratin in
hyperkeratotic skin
disorders. Each gram of RAYASAL contains salicylic acid 5.9% as the
active ingredient
and the following inactive ingredients: cetyl alcohol, disodium EDTA,
emulsifying wax,
glyceryl stearate SE, jojoba oil, PEG-100 stearate, phenoxyethanol,
propylene glycol,
purified water, sodium hydroxide, stearic acid, stearyl alcohol,
tocopheryl acetate, white
petrolatum, xanthan gum.
Salicylic acid has been shown to produce desquamation of the horny
layer of skin while
not affecting qualitative or quantitative changes in the structure of
the viable epidermis
. The mechanism of action has been attributed to the dissolution of
intercellular
cement substances
. In a study of the percutaneous absorption of salicylic acid 6% 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
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
have higher salicylate levels than those with common extracellular
space. (See
PRECAUTIONS).
The primary metabolites identified in the urine after topical
administration are salicyluric
acid (52%), salicylate glucuronides (42%), and free salicy