PERMETHRIN- permethrin cream 5% w/w cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ)

Available from:

NuCare Pharmaceuticals,Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Permethrin Cream 5% w/w is indicated for the treatment of infestation with  Sarcoptesscabiei  (scabies). Permethrin Cream 5% w/w is contraindicated in patients with known hypersensitivity to any of its components, to any synthetic pyrethroid or pyrethrin.

Product summary:

Permethrin Cream 5% w/w is available as follows: NDC 68071-1624-6 BOX OF 60G STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Makaim, Post: Mardol, Ponda Goa- 403 404- India. Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev 01 April 2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

PERMETHRIN- PERMETHRIN CREAM 5% W/W CREAM
NUCARE PHARMACEUTICALS,INC.
----------
PERMETHRIN CREAM 5% W/W
RX ONLY
DESCRIPTION
Permethrin Cream 5% w/w is a topical scabicidal agent for the
treatment of infestation
with _Sarcoptesscabiei_ (scabies). It is available in an off-white,
vanishing cream base.
Permethrin Cream 5% w/w is for topical use only.
CHEMICAL NAME - The permethrin used is an approximate 1:3 mixture of
the cis and
trans isomers of the pyrethroid 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropanecarboxylic acid, ( 3-phenoxyphenyl) methyl ester.
Permethrin has
a molecular formula of C
H
Cl
O
and a molecular weight of 391.29. It is a yellow to
light orange-brown, low melting solid or viscous liquid.
ACTIVE INGREDIENT - Each gram contains permethrin 50 mg (5%).
INACTIVE INGREDIENTS - Carbomer homopolymer type B, medium-chain
triglycerides,
glycerin, mono-and diglycerides, isopropyl myristate, lanolin
alcohols, mineral oil,
polyoxyethylene (20) cetyl ethers, purified water, and sodium
hydroxide. Formaldehyde
1 mg (0.1%) is added as a preservative.
CLINICAL PHARMACOLOGY
21
20
2
3
CLINICAL PHARMACOLOGY
Permethrin, a pyrethroid, is active against a broad range of pests
including lice, ticks,
fleas, mites, and other arthropods. It acts on the nerve cell membrane
to disrupt the
sodium channel current by which the polarization of the membrane is
regulated. Delayed
repolarization and paralysis of the pests are the consequences of this
disturbance.
Permethrin is rapidly metabolized by ester hydrolysis to inactive
metabolites which are
excreted primarily in the urine. Although the amount of permethrin
absorbed after a
single application of the 5% cream has not been determined precisely,
data from studies
with
C-labeled permethrin and absorption studies of the cream applied to
patients with
moderate to severe scabies indicate it is 2% or less of the amount
applied.
INDICATIONS AND USAGE
Permethrin Cream 5% w/w is indicated for the treatment of infestation
with
_ Sarcoptesscabiei _(scabies).
CONTRAINDICATIONS
Permet