KERALYT- salicylic acid kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

SUMMERS LABORATORIES INC

INN (International Name):

SALICYLIC ACID

Composition:

SALICYLIC ACID 6 g in 92.6 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 GEL should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. KERALYT should not be used in children under 2 years of age.

Product summary:

HOW SUPPLIED: 60 g Plastic bottle NDC 11086-030-60 Store at controlled room temperature 59° to 86° F (15° to 30° C)

Authorization status:

unapproved drug other

Summary of Product characteristics

KERALYT- SALICYLIC ACID
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 KIT (11086-047)
KERALYT
GEL
(SALICYLIC ACID) 6%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL
USE.
DESCRIPTION:KERALYT
is a gel for topical administration containing salicylic acid 6%,
in a vehicle composed of propylene glycol, SD-40 alcohol (21%),
hydroxypropylcellulose
and purified water. Salicylic acid is the 2 hydroxy derivative of
benzoic acid having the
following 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. 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 from KERALYT GEL 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 absorption differ from those after oral salicylate
administratio