SALICYLIC ACID liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Acella Pharmaceuticals, LLC

INN (International Name):

SALICYLIC ACID

Composition:

SALICYLIC ACID 275 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Salicylic Acid, 27.5% Wart Remover is indicated for the topical treatment and removal of common warts and plantar warts. Salicylic Acid, 27.5% Wart Remover should not be used by diabetics or patients with impaired blood circulation. Salicylic Acid, 27.5% Wart Remover should not be used on moles, birthmarks, unusual warts with hair growing from them or warts on the face.

Product summary:

Salicylic Acid, 27.5% Wart Remover is supplied in 10 mL amber bottles with a brush applicator, (NDC 42192-135-10).

Authorization status:

unapproved drug other

Summary of Product characteristics

SALICYLIC ACID- SALICYLIC ACID LIQUID
ACELLA 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, 27.5%
Wart Remover
RX ONLY
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL
USE.
DESCRIPTION:
Salicylic Acid, 27.5% Wart Remover is a topical preparation containing
27.5% salicylic
acid in a film-forming vehicle composed of isopropyl alcohol,
isobutyrate, acrylates
copolymer, N butyl acetate and polyvinyl butyrate. The pharmacologic
activity of Salicylic
Acid, 27.5% Wart Remover is generally attributed to the keratolytic
activity of salicylic
acid which is incorporated into a film-forming vehicle designed to
cover the wart without
the need for a bandage. The structural formula of salicylic acid is:
CLINICAL PHARMACOLOGY:
Although the exact mode of action for salicylic acid in the treatment
of warts is not
known, its activity appears to be associated with its keratolytic
action which results in
mechanical removal of epidermal cells infected with wart viruses.
INDICATIONS AND USES:
Salicylic Acid, 27.5% Wart Remover is indicated for the topical
treatment and removal of
common warts and plantar warts.
CONTRAINDICATIONS:
Salicylic Acid, 27.5% Wart Remover should not be used by diabetics or
patients with
impaired blood circulation. Salicylic Acid, 27.5% Wart Remover should
not be used on
moles, birthmarks, unusual warts with hair growing from them or warts
on the face.
PRECAUTIONS:
Salicylic Acid, 27.5% Wart Remover is for external use only. Do not
permit Salicylic Acid,
27.5% Wart Remover to contact eyes or mucous membranes. If contact
with eyes or
mucous membranes occurs, immediately flush with water for 15 minutes.
Salicylic Acid,
27.5% Wart Remover should not be allowed to contact normal skin
surrounding wart.
Treatment should be discontinued if excessive irritation occurs.
Salicylic Acid, 27.5%
Wart Remover is flammable and