Malathion (Page 2 of 2)

Pediatric Use

The safety and effectiveness of Malathion Lotion in children less than 6 years of age has not been established via well-controlled trials.

ADVERSE REACTIONS

Malathion has been shown to be irritating to the skin and scalp. Other adverse reactions reported are chemical burns including second-degree burns. Accidental contact with the eyes can result in mild conjunctivitis.

It is not known if Malathion Lotion has the potential to cause contact allergic sensitization.

OVERDOSAGE

Consideration should be given, as part of the treatment program, to the high concentration of isopropyl alcohol in the vehicle.

Malathion, although a weaker cholinesterase inhibitor than some other organophosphates, may be expected to exhibit the same symptoms of cholinesterase depletion after accidental ingestion orally. If accidentally swallowed, vomiting should be induced promptly or the stomach lavaged with 5% sodium bicarbonate solution.

Severe respiratory distress is the major and most serious symptom of organophosphate poisoning requiring artificial respiration, and atropine may be needed to counteract the symptoms of cholinesterase depletion.

Repeat analyses of serum and RBC cholinesterase may assist in establishing the diagnosis and formulating a long — range prognosis.

DOSAGE AND ADMINISTRATION

  1. Apply Malathion Lotion on DRY hair in amount just sufficient to thoroughly wet the hair and scalp. Pay particular attention to the back of the head and neck while applying Malathion Lotion. Wash hands after applying to scalp.
  2. Allow hair to dry naturally — use no electric heat source, and allow hair to remain uncovered.
  3. After 8 to 12 hours, the hair should be shampooed.
  4. Rinse and use a fine — toothed (nit) comb to remove dead lice and eggs.
  5. If lice are still present after 7 — 9 days, repeat with a second application of Malathion Lotion.

Further treatment is generally not necessary. Other family members should be evaluated by a physician to determine if infested, and if so, receive treatment.

Clinical Studies

Two controlled clinical trials evaluated the pediculicidal activity of Malathion Lotion. Patients applied the lotion to the hair and scalp in quantities, up to a maximum of 2 fl. oz., sufficient to thoroughly wet the hair and scalp. The lotion was allowed to air dry and was shampooed with Prell shampoo 8 to 12 hours after application. Patients in both the Malathion Lotion group and in the vehicle group were examined immediately after shampooing, 24 hours after, and 7 days after for the presence of live lice. Results are shown in the following table:

Number of Patients Without Live Scalp Lice
Treatment Immediately After 24 Hrs. After 7 Days After
Malathion Lotion 129/129 122/129 114/126
Malathion Vehicle 105/105 63/105 31/105

The presence or absence of ova at day 7 was not evaluated in these studies. The presence or absence of live lice or ova at 14 days following treatment was not evaluated in these studies. The residual amount of malathion on hair and scalp is unknown.

HOW SUPPLIED

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]”.

Manufactured For:

Suven Life Sciences Limited

1100, Cornwall Road,

Monmouth Junction, NJ 08852, USA.

Manufactured By:

Suven Life Sciences Limited

Unit-3, Plot No. 262 to 271, IDA,

Pashamylaram, Medak District,

Pin — 502307, Andhra Pradesh, India.

Date of Revision: November 2013

Lb30001-1-03

PRINCIPAL DISPLAY PANEL — 59 mL Bottle Carton

NDC 68022-0001-1

Malathion Lotion, USP 0.5%

Rx Only

In Isopropyl alcohol (78%)
terpineol, dipentene and
pine needle oil.

WARNING:
Contains flammable alcohol.
Avoid smoking, open flame and
hair dryers. Allow hair to dry
naturally and uncovered.

For topical use only.
Not for oral or ophthalmic use.

PEDICULICIDE / OVICIDE

2 fl. oz (59 mL)

Suven Life Sciences Limited

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MALATHION
malathion lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68022-0001
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MALATHION (MALATHION) MALATHION 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL
TERPINEOL
LIMONENE, (+/-)-
PINE NEEDLE OIL (PINUS SYLVESTRIS)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68022-0001-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 59 mL in 1 BOTTLE This package is contained within the CARTON (68022-0001-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091559 02/20/2014
Labeler — Suven Life Sciences Limited (677604288)
Establishment
Name Address ID/FEI Operations
Suven Life Sciences Limited 677604288 manufacture (68022-0001), analysis (68022-0001), api manufacture (68022-0001), label (68022-0001), pack (68022-0001)

Revised: 01/2020 Suven Life Sciences Limited

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