FDA-filed SPL labeling · retrieved through openFDA

Malathion Topical

Malathion topical is a prescription lice-killing treatment used on the scalp to treat head lice and their eggs.

Brand name Ovide
Drug class Cholinesterase Inhibitor
Rx Form 1 Route Topical
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJan 14, 2026
Clinical labels in scope 2
AvailabilityRx
Earliest approval/marketing year 1982
FDA-listed product records 6
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 21, 2026
Malathion Topical at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Malathion lotion is a proven prescription treatment for head lice and their eggs on the scalp. It works well when applied carefully and left on for 8 to 12 hours before rinsing. The most important safety points are keeping hair away from any heat source while the lotion is on, never using it on infants, and calling for help immediately if it is accidentally swallowed.

📖 Malathion Topical: Patient Information Guide

A plain-language walkthrough of Malathion Topical — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Malathion topical is used to treat head lice on the scalp hair.

  • Malathion and Ovide lotions are indicated for head lice (Pediculus humanus capitis) and their eggs (ova) on the scalp hair
⚙️How it works

Malathion is an organophosphate compound that works by blocking an enzyme called cholinesterase, which lice need for normal nerve function. When this enzyme is inhibited, the lice cannot survive. The same mechanism explains why accidental ingestion or large amounts absorbed through the skin can cause toxicity in people — your nervous system uses cholinesterase too.

Because the amount of malathion absorbed through the scalp during normal use is not fully characterized, it is important to follow dosing instructions carefully, especially for children.

💊How it's taken

Malathion lotion is applied topically — directly to dry scalp hair — in a quantity just sufficient to wet the hair and scalp thoroughly. Special attention should be paid to the back of the head and neck. The lotion is left on for 8 to 12 hours, then shampooed out, and a fine-toothed nit comb is used to remove dead lice and eggs.

  • A second application may be used if lice are still seen after 7 to 9 days
  • Further treatment beyond two applications is generally not necessary

Always follow your prescriber's specific instructions and the directions on the label.

🤒Side effects — in detail

The most common reactions involve the scalp and skin where the lotion is applied.

  • Scalp and skin irritation
  • Stinging sensation
  • Chemical burns, including second-degree burns
  • Mild eye redness or irritation (conjunctivitis) if lotion contacts the eyes

If you develop burns or irritation that doesn't clear after stopping use, or if your eyes remain irritated after flushing with water, contact your doctor.

⚠️Warnings & precautions
  • Flammability: Malathion lotion is highly flammable. While hair is wet with the lotion, stay away from open flames, lit cigarettes, hair dryers, and electric curlers. Let hair air-dry and remain uncovered.
  • Chemical burns: Second-degree burns and stinging have been reported. If irritation develops, rinse immediately. If irritation returns on reapplication, stop use and see a doctor.
  • Eye contact: If lotion gets in the eyes, flush immediately with water. Seek medical advice if irritation or vision changes persist.
  • Children: Must be used only under direct adult supervision. Safety and effectiveness in children under 6 have not been well established. Never use on newborns or infants.
  • Accidental swallowing: Seek emergency medical help immediately if the lotion is ingested.
  • Pregnancy and breastfeeding: Consult your doctor before using if you are pregnant or nursing.
🔀What it interacts with

No specific drug interactions are described in the labeling, but one important substance consideration is noted.

  • Isopropyl alcohol (in the vehicle): The lotion contains a high concentration of isopropyl alcohol, which must be considered — especially in the event of accidental ingestion

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Newborns and infants: Do not use — their scalps are more permeable and may absorb too much malathion
  • Allergy: Do not use if you are sensitive to malathion or any ingredient in the lotion
  • Children under 6: Safety and effectiveness have not been established in well-controlled trials
  • Children (any age): Must be applied under direct adult supervision; children should be warned to keep away from flames and heat sources while hair is wet
  • Pregnancy: Animal studies did not show harm, but consult your doctor before using — use only if clearly needed
  • Breastfeeding: It is not known if malathion passes into breast milk; use caution and consult your doctor
🚑If you take too much

If malathion lotion is accidentally swallowed, seek emergency medical help immediately. Swallowed malathion can cause symptoms of cholinesterase overload — such as excessive sweating, drooling, stomach cramps, slow heartbeat, and severe breathing difficulty. Emergency treatment may include inducing vomiting, stomach lavage (washing out the stomach), assisted breathing, and the medication atropine to counteract the effects.

📡Pharmacodynamics — effects in the body

Malathion works by inhibiting cholinesterase — an enzyme the nervous system needs to regulate nerve signals. In lice, blocking this enzyme is fatal. In people, too much cholinesterase inhibition (from accidental ingestion or large skin absorption) can overstimulate the nervous system, causing increased secretions, digestive cramping, slow heart rate, and serious breathing problems.

🔬Pharmacokinetics — how your body processes it

The exact amount of malathion absorbed through the scalp from the lotion formulation is not fully known. Studies with malathion in an acetone vehicle showed about 8% of the applied dose can be absorbed through human skin, but absorption from the lotion formulation specifically has not been fully characterized. Actual systemic exposure is expected to be less than 10% of the dose applied.

📦How to store it

Store at 20° to 25°C (68° to 77°F) . Keep away from heat and open flame.

📄 Written from Malathion Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

17

Supplements & herbs that interact with Malathion Topical

17 supplements and herbal products have documented interactions with Malathion Topical in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 7
  • Minor · 9
Every supplement checked against Malathion Topical — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Malathion Topical against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Malathion Topical — the kind of thing our pharmacy team would talk through with you at the counter.

How exactly do I use malathion lotion — do I put it on wet or dry hair?
Always apply it to dry hair. Work the lotion through your hair and scalp until everything is thoroughly wet, and pay extra attention to the back of the head and neck where lice like to hide. Wash your hands right after. Then let your hair air-dry completely — no hair dryer, no electric curlers — and leave it uncovered. After 8 to 12 hours, shampoo it out, rinse, and use a fine-toothed nit comb to remove any dead lice and eggs.
Why can't I use a hair dryer after applying the lotion?
The lotion is highly flammable — that's a real fire risk, not just a precaution. While your hair is wet with the lotion, you also need to stay away from lit cigarettes, open flames, and electric heat sources of any kind. Let your hair dry naturally and stay uncovered the whole time.
What should I do if the lice are still there after the first treatment?
If you still see live lice 7 to 9 days after the first application, you can do a second treatment. Beyond that, a second application is usually all that's needed. Make sure other family members get checked by a doctor too, because lice spread easily — treating just one person often isn't enough.
Is it safe to use on my young child?
This lotion should never be used on newborns or infants — their scalps absorb the medication much more readily, which can be dangerous. For children, it must always be applied by an adult, and kids should be kept away from flames and heat while their hair is wet. The safety and effectiveness in children under 6 hasn't been firmly established through well-controlled studies, so talk to your child's doctor before using it on a young child.
The lotion is burning my scalp — is that normal, and what should I do?
Some stinging or irritation is a known side effect, but the lotion can also cause more serious chemical burns, including second-degree burns. If you notice significant irritation, rinse your scalp and hair right away with water. Once the irritation clears, you can try reapplying. But if the irritation comes back when you try again, stop use and call your doctor.
Can I use this if I'm pregnant or breastfeeding?
It's not a flat-out no, but you should talk to your doctor first. Animal studies didn't show harm to the fetus, but the research in humans is limited. It also isn't known whether malathion passes into breast milk. Your doctor can weigh the risk and help you decide if this is the right option for you right now.
Is Malathion Topical available over the counter?
Malathion Topical is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Malathion Topical first available?
Malathion Topical has been available in the United States since at least 1982, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Malathion Topical?
Malathion Topical is supplied by 3 manufacturers listed in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Suven Pharmaceuticals Limited, Taro Pharmaceuticals U.S.A., Inc..

💬 Answers drafted from Malathion Topical’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Malathion Topical comes

Malathion Topical is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Topical cream, ointment or gel

On the skin
Brands Ovide
How this form is used
What it may be used for
  • Malathion and Ovide are used to treat head lice and their eggs on the scalp hair
Important instructions
  • Apply to dry scalp hair in an amount just enough to thoroughly wet the hair and scalp, paying extra attention to the back of the head and neck
  • Wash hands immediately after applying
  • Allow hair to air-dry naturally — do not use a hair dryer or any electric heat source, and leave hair uncovered
  • After 8 to 12 hours, shampoo, rinse, and comb with a fine-toothed nit comb to remove dead lice and eggs; repeat with a second application if lice are still present after 7 to 9 days
Available strengths 2 strengths
6 FDA-listed product records

📊 Malathion Topical across the U.S. market

How Malathion Topical appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
3
Manufacturers
2
Brand names
6
FDA-listed product records
1982
First marketed
Sun Pharmaceutical Industries, Inc.33%
Suven Pharmaceuticals Limited33%
Taro Pharmaceuticals U.S.A., Inc.33%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Malathion Topical is used

A general measure of how commonly Malathion Topical is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Malathion Topical is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

4,594
Medicaid prescriptions filled (Q1–Q4 2025)
$916,297 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Malathion Topical prescribed? Of the 1,596 medications we measure, Malathion Topical ranks #1,057 by Medicaid prescriptions — more than 34% of them.

Where Malathion Topical ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Malathion Topical product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Malathion Topical products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

4,594 Medicaid prescriptions (Q1–Q4 2025) 100% of Malathion Topical prescriptions shown $916,297 gross reimbursement (before rebates) ≈ $199 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Malathion Topical, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Malathion Topical NDCs with Medicaid activity.

🔍 Compare Malathion Topical products

A representative set of FDA-listed product records for Malathion Topical — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Topical cream, ointment or gel
0.0005 g/mL Topical Sun Pharmaceutical Industries, Inc. × 2 listings ANDA View NDC →
0.005 g/mL Topical Suven Pharmaceuticals Limited × 2 listings ANDA View NDC →
0.0005 g/mL Topical Taro Pharmaceuticals U.S.A., Inc. × 2 listings ANDA View NDC →

Showing 6 of 6 products — FDA National Drug Code Directory. See every product, package size and price: browse all 6 Malathion Topical NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Malathion Topical RxCUI 6606 2 dose forms · 2 strengths
  1. Dose form (SCDF) Medicated Shampoo RxCUI 393231 In current FDA listings
    Clinical drug / strength (SCD) 10 MG/ML RxCUI 142051
  2. Dose form (SCDF) Topical Lotion RxCUI 378990 In current FDA listings
    Clinical drug / strength (SCD) 5 MG/ML RxCUI 204119

Look up RxCUI 6606 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Ovide

🏭 Manufacturers & labelers

Sun Pharmaceutical Industries, Inc. 2 Suven Pharmaceuticals Limited 2 Taro Pharmaceuticals U.S.A., Inc. 2

RxNorm drug class

Malathion Topical belongs to the Cholinesterase Inhibitor class.

Pharmacologic class Cholinesterase Inhibitor
Drug family (ATC) Other ectoparasiticides, incl. scabicides
How it works Cholinesterase Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 14, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Malathion Topical.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Malathion Topical after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
6
Distinct labelers/manufacturers represented
3
Linked representative label
Taro Pharmaceuticals U.S.A., Inc.
Linked label effective
Jan 14, 2026
Composite sections available
15
Linked SPL Set ID
a0b1444b-f51b-44fd-8f23-2fff49b64bc0
Linked SPL Document ID
48601e44-5f35-5e10-e063-6394a90a5801
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 2 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Taro Pharmaceuticals U.S.A., Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.