MALATHION lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MALATHION (UNII: U5N7SU872W) (MALATHION - UNII:U5N7SU872W)

Available from:

Suven Pharmaceuticals Limited

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Malathion Lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair. Malathion Lotion is contraindicated for neonates and infants because their scalps are more permeable and may have increased absorption of malathion. Malathion Lotion should also not be used on individuals known to be sensitive to malathion or any of the ingredients in the vehicle.

Product summary:

Malathion Lotion USP, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 68022-0001-1. “Store at 20° to 25°C (68° to 77°F) [See USP controlled Room Temperature]”.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MALATHION- MALATHION LOTION
SUVEN PHARMACEUTICALS LIMITED
----------
MALATHION LOTION USP, 0.5%
RX ONLY
For topical use only. Not for oral or ophthalmic use.
DESCRIPTION
Malathion Lotion contains 0.005 g of malathion per mL in a vehicle of
isopropyl alcohol
(78%), terpineol, dipentene, and pine needle oil. The chemical name of
malathion is (±) -
[(dimethoxyphosphinothioyl) - thio] butanedioic acid diethyl ester.
Malathion has a
molecular weight of 330.36, represented by C10H19O6PS2, and has the
following
chemical structure:
CLINICAL PHARMACOLOGY
Malathion is an organophosphate agent which acts as a pediculicide by
inhibiting
cholinesterase activity in vivo. Inadvertent transdermal absorption of
malathion has
occurred from its agricultural use. In such cases, acute toxicity was
manifested by
excessive cholinergic activity, i.e., increased sweating, salivary and
gastric secretion,
gastrointestinal and uterine motility, and bradycardia (see
OVERDOSAGE). Because the
potential for transdermal absorption of malathion from Malathion
Lotion is not known at
this time, strict adherence to the dosing instructions regarding its
use in children,
method of application, duration of exposure, and frequency of
application is required.
INDICATIONS AND USAGE
Malathion Lotion is indicated for patients infected with Pediculus
humanus capitis (head
lice and their ova) of the scalp hair.
CONTRAINDICATIONS
Malathion Lotion is contraindicated for neonates and infants because
their scalps are
more permeable and may have increased absorption of malathion.
Malathion Lotion
should also not be used on individuals known to be sensitive to
malathion or any of the
ingredients in the vehicle.
WARNINGS
1. Malathion Lotion is flammable. The lotion and wet hair should not
be exposed to open
flames or electric heat sources, including hair dryers and electric
curlers. Do not
smoke while applying lotion or while hair is wet. Allow hair to dry
naturally and to
remain uncovered after application of Malathion Lotion.
2. Malathion Lotion should only be us