FDA-filed SPL labeling · retrieved through openFDA

Mechlorethamine

Mechlorethamine is an alkylating drug used topically to treat Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (a type of skin lymphoma).

Brand names MustargenValchlor
Drug class Alkylating Drug
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 1 clinical label set 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 effectiveNov 20, 2024
AvailabilityRx
Earliest approval/marketing year 1949
FDA-listed product records 4
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 23, 2026
Other forms & routes:
Mechlorethamine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Valchlor is a prescription gel used to treat an early-stage form of skin lymphoma in people who have already tried other skin treatments. Skin irritation is common, so monitor your skin closely and follow your doctor's guidance on when to pause or reduce use. This drug can harm a fetus and should not be used during pregnancy.

📖 Mechlorethamine: Patient Information Guide

A plain-language walkthrough of Mechlorethamine — 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

Mechlorethamine is an alkylating drug approved for topical treatment of a specific type of skin lymphoma. Its supported use is product-specific:

  • Valchlor (mechlorethamine gel): Treats Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma — an early-stage form of lymphoma that primarily involves the skin — in patients who have already received other skin-directed treatments.
⚙️How it works

Mechlorethamine is an alkylating agent, sometimes called a nitrogen mustard. It works by chemically bonding to DNA inside rapidly dividing cells, disrupting their ability to replicate. This targets the abnormal lymphoma cells growing in the skin and helps slow or stop the disease. When Valchlor is applied to the skin, it works locally — studies showed no detectable levels of mechlorethamine entering the bloodstream after topical application.

💊How it's taken

Valchlor gel is applied topically once daily as a thin film to affected areas of the skin. It should be applied to completely dry skin — at least 4 hours before or 30 minutes after showering or washing. Allow the treated area to dry for 5–10 minutes before covering with clothing. Moisturizers may be applied 2 hours before or 2 hours after application. Do not use occlusive (airtight) dressings over treated areas. Always follow your prescriber's specific instructions; if your skin reacts severely, your doctor may reduce the frequency or pause treatment.

🤒Side effects — in detail

The most common side effects with Valchlor involve the skin:

  • Dermatitis (skin redness, swelling, inflammation) — the most common reaction, occurring in more than half of patients
  • Itchiness (pruritus)
  • Bacterial skin infection
  • Skin blistering or ulceration
  • Skin darkening (hyperpigmentation)

Severe skin reactions — including bad blistering, open sores, or moderately-severe dermatitis — may require pausing or stopping treatment. Call your doctor right away if these develop. A small number of patients also developed non-melanoma skin cancer during or after treatment, so ongoing skin monitoring is important.

⚠️Warnings & precautions
  • Eye and mucosal injury: If Valchlor contacts your eyes, it can cause severe pain, burns, and potentially permanent blindness. Rinse immediately with large amounts of water for at least 15 minutes and get urgent medical care. Contact with the mouth or nasal lining can also cause painful ulcers.
  • Skin reactions (dermatitis): More than half of patients experienced dermatitis. The face, genitals, anus, and skin folds are especially vulnerable. Monitor your skin and follow your doctor's instructions about dose adjustments.
  • Non-melanoma skin cancer: A small percentage of patients developed non-melanoma skin cancer during or after treatment. Skin monitoring during and after treatment is important.
  • Embryo-fetal toxicity: Mechlorethamine may cause serious harm to a developing baby. Women should avoid becoming pregnant during treatment; both male and female patients should use effective contraception.
  • Secondary exposure: People other than the patient should not touch Valchlor. Caregivers must wear nitrile gloves when applying it and wash hands immediately afterward.
  • Flammable: Valchlor is an alcohol-based gel. Avoid fire, flame, and smoking until the gel has completely dried on the skin.
🔀What it interacts with

No formal drug interaction studies have been conducted with Valchlor. Because the drug is not detectably absorbed into the bloodstream after topical use, systemic drug interactions are considered unlikely. Discuss all medications, supplements, and skin products you use with your doctor or pharmacist.

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
  • Severe allergy to mechlorethamine: Valchlor is contraindicated (must not be used) if you have a known severe allergic reaction — including anaphylaxis — to mechlorethamine.
  • Pregnancy: Mechlorethamine may cause fetal harm, including birth defects. Do not use Valchlor if you are pregnant, and use effective contraception during treatment.
  • Breastfeeding: Do not breastfeed while using Valchlor; the drug could expose your infant through skin contact or systemic transfer.
  • Males of reproductive potential: Use effective contraception during treatment, and use a barrier method to prevent direct exposure of reproductive organs to the gel.
  • Children: Safety and effectiveness in pediatric patients have not been established.
  • Older adults (65+): Older patients may experience more skin-related side effects and are more likely to discontinue treatment. Close monitoring is recommended.
  • Fertility: Mechlorethamine may impair fertility in both males and females; whether this is reversible is not known.
🔬Pharmacokinetics — how your body processes it

When Valchlor gel is applied to the skin, systemic absorption is not detectable. In clinical studies, patients using mechlorethamine gel at 0.016% had no measurable drug levels in their blood on the day of application or at one month. Patients using a higher concentration (0.032%) also had no measurable levels of mechlorethamine or its breakdown products after 2, 4, or 6 months of treatment. This means the drug acts locally in the skin with no meaningful amount entering the bloodstream.

📦How to store it

store in the freezer at -13°F to 5°F (-25°C to -15°C). refrigerated storage is required once dispensed.

📄 Written from Mechlorethamine’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 Mechlorethamine

17 supplements and herbal products have documented interactions with Mechlorethamine 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 Mechlorethamine — ranked by severity The full interaction hub: 1 major · 7 moderate · 9 minor · every one linked to its full report. Check Mechlorethamine 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 Mechlorethamine — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is Valchlor being used to treat?
Valchlor is used to treat a specific type of skin lymphoma called mycosis fungoides-type cutaneous T-cell lymphoma, but only in its earlier stages — Stage IA and IB. It's for people who have already tried at least one other skin-focused treatment. Think of it as a targeted treatment applied directly to the skin where the lymphoma is showing up.
How do I apply Valchlor correctly, and are there any special steps I need to follow?
Apply a thin film of Valchlor gel once a day to the affected skin areas — but only after the skin is completely dry, meaning at least 4 hours before or 30 minutes after bathing. Take it out of the refrigerator, use it within 30 minutes, and put it right back. Let it dry on your skin for 5 to 10 minutes before putting clothes on. Wash your hands thoroughly with soap and water after applying it. If a caregiver is applying it for you, they must wear disposable nitrile gloves every time.
What side effects should I watch out for?
Skin irritation — redness, itching, swelling, or inflammation — is the most common side effect and happened in more than half of patients in studies. Milder irritation is expected, but if you develop severe redness with swelling, blistering, or open sores, stop using it and call your doctor right away. Your doctor may lower how often you apply it and then slowly work back up. Also watch for any new or changing skin spots, and let your doctor know — there's a small risk of non-melanoma skin cancer with this treatment.
What happens if Valchlor gets in my eyes or mouth?
That's a real emergency. If it gets in your eyes, rinse immediately with large amounts of water for at least 15 minutes and go straight to urgent care or an eye doctor — serious, even permanent eye damage can occur if not treated fast. If it contacts your mouth or nose, rinse thoroughly with water for 15 minutes and get medical advice. This is why it's so important to be careful during application and to keep the gel away from your face.
Is it safe to use Valchlor if I'm pregnant or trying to get pregnant?
No — you should not use Valchlor if you are pregnant or planning to become pregnant. Mechlorethamine can cause serious harm to a developing baby. Both women and men using this treatment should use effective contraception during therapy. If you become pregnant while using Valchlor, contact your doctor right away. Breastfeeding is also not recommended while on this treatment.
Is it safe for people around me to be near Valchlor?
People other than you — including caregivers, partners, or children — should not touch the gel or your skin in the treated area until it has fully dried. The gel can cause skin reactions and other harm in people who are accidentally exposed. Caregivers applying the gel must wear disposable nitrile gloves and wash their hands thoroughly afterward. Also keep in mind: Valchlor is flammable until it dries, so avoid fire, open flames, and smoking right after application.
Is Mechlorethamine available over the counter?
Mechlorethamine 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 Mechlorethamine first available?
Mechlorethamine has been available in the United States since at least 1949, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Mechlorethamine?
Mechlorethamine is supplied by 2 manufacturers listed in the FDA NDC Directory, including Helsinn Therapeutics (U.S.), Inc., Sigma-Aldrich Corporation.

💬 Answers drafted from Mechlorethamine’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 Mechlorethamine comes

Mechlorethamine 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 Valchlor
How this form is used
What it may be used for
  • Valchlor is used to treat Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy
Important instructions
  • Valchlor: Apply a thin film once daily to affected areas of dry skin
  • Valchlor: Apply immediately or within 30 minutes of removing from the refrigerator, then return it to the refrigerator right after use
  • Valchlor: Apply to skin that is completely dry — at least 4 hours before or 30 minutes after showering or washing; allow treated area to dry 5–10 minutes before covering with clothing
  • Valchlor: Patients must wash hands thoroughly with soap and water after applying; caregivers must wear disposable nitrile gloves during application
Available strengths 1 strength
3 FDA-listed product records

📊 Mechlorethamine across the U.S. market

How Mechlorethamine 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
2
Manufacturers
1
Brand names
4
FDA-listed product records
1949
First marketed

Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Helsinn Therapeutics (U.S.), Inc.75%
Sigma-Aldrich Corporation25%

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

📈 How widely Mechlorethamine is used

A general measure of how commonly Mechlorethamine 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 Mechlorethamine 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.

118
Medicaid prescriptions filled (Q1–Q4 2025)
$1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Mechlorethamine prescribed? Of the 1,596 medications we measure, Mechlorethamine ranks #1,489 by Medicaid prescriptions — more than 7% of them.

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

Utilization by Mechlorethamine 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.

mechlorethamine 0.00016 MG/MG Topical Gel

118 Medicaid prescriptions (Q1–Q4 2025) 100% of Mechlorethamine prescriptions shown $1M gross reimbursement (before rebates) ≈ $8,709 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1437711

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 Mechlorethamine, 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 1 listed Mechlorethamine NDCs with Medicaid activity.

🔍 Compare Mechlorethamine products

A representative set of FDA-listed product records for Mechlorethamine — 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
0.012 g/60 g Topical Helsinn Therapeutics (U.S.), Inc. × 3 listings NDA View NDC →
💊Bulk drug substance
1 g/g Sigma-Aldrich Corporation BULK INGREDIENT View NDC →

Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Mechlorethamine 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) Mechlorethamine RxCUI 6674 1 dose form · 1 strength
  1. Dose form (SCDF) Topical Gel RxCUI 1437554 In current FDA listings
    Clinical drug / strength (SCD) 0.00016 MG/MG RxCUI 1437711

Look up RxCUI 6674 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

Mustargen Valchlor

🏭 Manufacturers & labelers

Helsinn Therapeutics (U.S.), Inc. 3 Sigma-Aldrich Corporation 1

RxNorm drug class

Mechlorethamine belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Nitrogen mustard analogues
How it works Alkylating Activity

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 Nov 20, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Mechlorethamine.
📈
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 Mechlorethamine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
NDC products indexed
4
Distinct labelers/manufacturers represented
2
Linked representative label
Helsinn Therapeutics (U.S.), Inc.
Linked label effective
Nov 20, 2024
Composite sections available
23
Linked SPL Set ID
6a52e4c2-6a9f-4ebb-bc77-046b4f8bcd57
Linked SPL Document ID
942707af-a16c-4a62-b733-103e0fac915e
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 1 FDA-filed SPL label set 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.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. 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. Helsinn Therapeutics (U.S.), 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.