Non-medicated VALCHLOR ® Demonstration Gel
- Manufacturer
- Actelion Pharmaceuticals US, Inc. | Actelion Pharmaceuticals, Ltd.
- Effective date
- 2018-12-13
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:40:13
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
Instructions For UseReference VALCHLOR US Prescribing Information
Non-medicated VALCHLOR® Demonstration Gel DOES NOT contain mechlorethamine (the medicine in VALCHLOR).
The purpose of VALCHLOR Demonstration Gel is to show healthcare providers and patients how to properly apply VALCHLOR. This will also allow the user to experience the consistency of VALCHLOR and how it may feel on the skin.
This information does not take the place of talking to your healthcare provider about your condition or your treatment.
How should VALCHLOR Demonstration Gel be used?
- Use VALCHLOR Demonstration Gel on clean and dry, healthy skin
- If you take a bath or shower, be sure to use the gel after your skin is dry (at least 30 minutes after bathing or showering)
How to use VALCHLOR Demonstration Gel:
| STEP 1: Open the 5g tube, use cap to puncture seal | |
| STEP 2: Squeeze a small pea-sized amount on your fingertip | |
| STEP 3: Gently spread a thin layer of the gel to dry healthy skin | |
| STEP 4: Allow the gel to dry before covering with clothing (5 to 10 minutes after applying) | |
| STEP 5: Throw the tube away in the household trash | |
| STEP 6: Wash your hands with soap and water |
Some Important Do's and Don'ts about VALCHLOR Demonstration Gel:
- When applying VALCHLOR Demonstration Gel, avoid the eyes, mouth, and nose.
- VALCHLOR Demonstration Gel should only be used on healthy skin since it is non-medicated.
- The 5g tube of VALCHLOR Demonstration Gel is meant for single use only.
- VALCHLOR Demonstration Gel contains alcohol. Since alcohol-based gels are flammable, avoid fire, flame, and smoking until the gel has dried.
- VALCHLOR Demonstration Gel can be stored at room temperature.
- Keep out of reach of children.
This demonstration gel contains the following nonactive ingredients: diethylene glycol monoethyl ether, propylene glycol, isopropyl alcohol, glycerin, lactic acid, hydroxypropylcellulose, sodium chloride, menthol, edetate disodium, and butylated hydroxytoluene.
Please see VALCHLOR full Prescribing Information including Medication Guide for information for active drug product.
To report SUSPECTED ADVERSE REACTIONS to the VALCHLOR Demonstration Gel, contact Actelion Pharmaceuticals US, Inc., at 1-855-4-VALCHLOR (1-855-482-5245) or FDA at 1-800-FDA-1088 or visit
www.fda.gov/medwatch.
The NDC code for the Non-medicated VALCHLOR Demonstration Gel is 66215-001-05.
ACT20151217
PRINCIPAL DISPLAY PANEL - 5 g Tube Carton
Products#
Every source-derived product name is available through these pages.
- Non-medicated VALCHLOR Demonstration
- diethylene glycol monoethyl ether
- propylene glycol
- isopropyl alcohol
- glycerin
- LACTIC ACID, UNSPECIFIED FORM
- hydroxypropyl cellulose (1600000 WAMW)
- sodium chloride
- Racementhol
- edetate disodium
- butylated hydroxytoluene
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66215-001 | 66215-001-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202317-001 | VALCHLOR | MECHLORETHAMINE HYDROCHLORIDE | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202317-001 | 7838564 | 2026-03-07 | Drug product | 2013-09-13 | |
| N202317-001 | 8450375 | 2026-03-07 | Drug product | 2013-09-13 | |
| N202317-001 | 8501818 | 2026-03-07 | Drug product | 2013-09-13 | |
| N202317-001 | 8501819 | 2026-03-07 | U-1427 | 2013-09-13 | |
| N202317-001 | 9382191 | 2026-03-07 | Drug product | 2016-07-26 | |
| N202317-001 | 7872050 | 2029-07-08 | U-1427 | 2013-09-13 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N202317-001 | VALCHLOR | EQ 0.016% BASE | GEL / TOPICAL | RLD, RS | 2013-08-23 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202317-001 | 7838564 | 2026-03-07 | Drug product | 2013-09-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202317-001 | 8450375 | 2026-03-07 | Drug product | 2013-09-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202317-001 | 8501818 | 2026-03-07 | Drug product | 2013-09-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202317-001 | 8501819 | 2026-03-07 | U-1427 | 2013-09-13 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202317-001 | 9382191 | 2026-03-07 | Drug product | 2016-07-26 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202317-001 | 7872050 | 2029-07-08 | U-1427 | 2013-09-13 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N202317-001 | 7838564 | 2026-03-07 | Drug product | 2013-09-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202317-001 | 8450375 | 2026-03-07 | Drug product | 2013-09-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202317-001 | 8501818 | 2026-03-07 | Drug product | 2013-09-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202317-001 | 8501819 | 2026-03-07 | U-1427 | 2013-09-13 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202317-001 | 9382191 | 2026-03-07 | Drug product | 2016-07-26 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202317-001 | 7872050 | 2029-07-08 | U-1427 | 2013-09-13 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202317-001 | 7838564 | 2026-03-07 | Drug product | 2013-09-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202317-001 | 8450375 | 2026-03-07 | Drug product | 2013-09-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202317-001 | 8501818 | 2026-03-07 | Drug product | 2013-09-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202317-001 | 8501819 | 2026-03-07 | U-1427 | 2013-09-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202317-001 | 9382191 | 2026-03-07 | Drug product | 2016-07-26 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202317-001 | 7872050 | 2029-07-08 | U-1427 | 2013-09-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202317-001 | 7838564 | 2026-03-07 | Drug product | 2013-09-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202317-001 | 8450375 | 2026-03-07 | Drug product | 2013-09-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202317-001 | 8501818 | 2026-03-07 | Drug product | 2013-09-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202317-001 | 8501819 | 2026-03-07 | U-1427 | 2013-09-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202317-001 | 9382191 | 2026-03-07 | Drug product | 2016-07-26 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202317-001 | 7872050 | 2029-07-08 | U-1427 | 2013-09-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202317-001 | 7838564 | 2026-03-07 | Drug product | 2013-09-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202317-001 | 8450375 | 2026-03-07 | Drug product | 2013-09-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202317-001 | 8501818 | 2026-03-07 | Drug product | 2013-09-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202317-001 | 8501819 | 2026-03-07 | U-1427 | 2013-09-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202317-001 | 9382191 | 2026-03-07 | Drug product | 2016-07-26 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202317-001 | 7872050 | 2029-07-08 | U-1427 | 2013-09-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202317-001 | 7838564 | 2026-03-07 | Drug product | 2013-09-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202317-001 | 8450375 | 2026-03-07 | Drug product | 2013-09-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202317-001 | 8501818 | 2026-03-07 | Drug product | 2013-09-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202317-001 | 8501819 | 2026-03-07 | U-1427 | 2013-09-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202317-001 | 9382191 | 2026-03-07 | Drug product | 2016-07-26 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202317-001 | 7872050 | 2029-07-08 | U-1427 | 2013-09-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202317-001 | 7838564 | 2026-03-07 | Drug product | 2013-09-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202317-001 | 8450375 | 2026-03-07 | Drug product | 2013-09-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202317-001 | 8501818 | 2026-03-07 | Drug product | 2013-09-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202317-001 | 8501819 | 2026-03-07 | U-1427 | 2013-09-13 | b8a1b40f171c… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N202317-001 | ODE-51 | 2020-08-23 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N202317-001 | ODE-51 | 2020-08-23 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N202317-001 | ODE-51 | 2020-08-23 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N202317-001 | ODE-51 | 2020-08-23 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N202317-001 | ODE-51 | 2020-08-23 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N202317-001 | ODE-51 | 2020-08-23 | ea99ee380514… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3e31b950-1f3d-4e3b-80c6-0bb7b7a8d54b | ad49e1df-e104-4e0e-9d6e-adb5f327d0e3 | 2018-12-13 | 3e31b950-1f3d-4e3b-80c6-0bb7b7a8d54b ad49e1df-e104-4e0e-9d6e-adb5f327d0e3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.






