OVIDE- malathion lotion

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TARO PHARMACEUTICALS USA, INC.

INN (International Name):

MALATHION

Composition:

MALATHION 0.005 g in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

OVIDE® (malathion) Lotion, 0.5%, is supplied in bottles of 2 fl. oz. (59 mL) NDC 51672-5276-4. Store at controlled room temperature 20° - 25°C (68° - 77°F). Flammable. Keep away from heat and open flame.

Authorization status:

New Drug Application

Summary of Product characteristics

OVIDE- MALATHION LOTION
TARO PHARMACEUTICALS USA, INC.
----------
OVIDE (MALATHION) LOTION, 0.5%
NDC 51672-5276-4
RX ONLY
For topical use only. Not for oral or ophthalmic use.
DESCRIPTION
OVIDE 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
C
H O PS , 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
OVIDE 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
OVIDE Lotion is indicated for patients infected with _Pediculus
humanus capitis_ (head lice and their ova)
of the scalp hair.
CONTRAINDICATIONS
OVIDE Lotion is contraindicated for neonates and infants because their
scalps are more permeable and
may have increased absorption of malathion. OVIDE Lotion should also
not be used on individuals
known to be sensitive to malathion or any of the ingredients in the
vehicle.
WARNINGS
1. OVIDE 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
®
10
19
6
2
or while hair is wet.
Allow hair to dry naturally and to remain uncovered after application
of OVIDE Lotion.
2. OVIDE Lotion should only be u