KERALYT- salicylic acid shampoo

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Summers Laboratories Inc

INN (Alþjóðlegt nafn):

SALICYLIC ACID

Samsetning:

SALICYLIC ACID 6 g in 92.6 mL

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

INDICATIONS AND USAGE - For the removal of excess keratin in hyperkeratotic disorders, including scaling associated with scalp psoriasis or thickened skin of palms and soles, corns and calluses. CONTRAINDICATIONS: KERALYT SHAMPOO should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. KERALYT SHAMPOO should not be used in children under 2 years of age.

Vörulýsing:

HOW SUPPLIED: 160 mL plastic bottles NDC 11086-043-06 Store at controlled room temperature 59° to 86° F (15° to 30° C)

Leyfisstaða:

unapproved drug other

Vara einkenni

KERALYT- SALICYLIC ACID SHAMPOO
SUMMERS LABORATORIES INC
_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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SUMMERS LABS (AS PLD) - KERALYT SHAMPOO (11086-043)
DESCRIPTION:KERALYT® shampoo contains 6% w/w salicylic acid USP in a
vehicle
composed of purified water, ammonium lauryl sulfosuccinate,
cocamidopropyl betaine,
hexylene glycol, linoleamidopropyl PG-dimonium chloride phosphate,
polyquaternium-22,
propylene glycol, sodium C14-16 olefin sulfonate, sodium citrate,
sodium lauroyl
sarcosinate, tetrasodium EDTA, tocopherol acetate and fragrance.
Salicylic acid is the 2 hydroxy derivative of benzoic acid
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. ¹, ²The mechanism of action has
been attributed to a
dissolution of intercellular cement substance. ³In a study of the
percutaneous
absorption of salicylic acid in four patients with extensive active
psoriasis, Taylor and
Halprin ⁴showed 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 have higher
salicylate levels than
those with a normal extracellular space. ⁵(See PRECAUTIONS).
The major metabolites identified in the urine after topical
administration are salicyluric
acid (52%), salicylate glucuronides (42%), and free salicylic acid
(6%). ⁴The urinary
metabolites after percutaneous