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#

ProductNon-medicated VALCHLOR Demonstration
Label structure2 sections

Label contents#

Full prescribing information#

Instructions For UseReference VALCHLOR US Prescribing Information

INSTRUCTIONS FOR USE SECTION

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 1STEP 1STEP 1: Open the 5g tube, use cap to puncture seal
STEP 2STEP 2STEP 2: Squeeze a small pea-sized amount on your fingertip
STEP 3STEP 3STEP 3: Gently spread a thin layer of the gel to dry healthy skin
STEP 4STEP 4STEP 4: Allow the gel to dry before covering with clothing (5 to 10 minutes after applying)
STEP 5STEP 5STEP 5: Throw the tube away in the household trash
STEP 6STEP 6STEP 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-medicated VALCHLOR®
Demonstration Gel
5 grams

For demonstration purposes only. Does not contain active ingredient.
For topical use only.

NDC 66215-001-05

PRINCIPAL DISPLAY PANEL - 5 g Tube Carton
PRINCIPAL DISPLAY PANEL - 5 g Tube Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66215-00166215-001-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202317-001VALCHLORMECHLORETHAMINE HYDROCHLORIDEEQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N202317-00178385642026-03-07Drug product2013-09-13
N202317-00184503752026-03-07Drug product2013-09-13
N202317-00185018182026-03-07Drug product2013-09-13
N202317-00185018192026-03-07U-14272013-09-13
N202317-00193821912026-03-07Drug product2016-07-26
N202317-00178720502029-07-08U-14272013-09-13

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-2384e616aacf4f…
2026-08-18 06:07:402026-07N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-234b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-2374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-2387673890dc5c…
2021-03-12 10:30 UTC2021-03N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-235aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-233f01610625f2…
2019-09-15 20:21 UTC2019-09N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-236a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-231c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-239b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-233f0d92c62455…
2023-05-13 08:27 UTC2023-05N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23053a50430f4f…
2023-01-26 05:58 UTC2023-01N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-233bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-233a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N202317-001VALCHLOREQ 0.016% BASEGEL / TOPICALRLD, RS2013-08-23f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N202317-00178385642026-03-07Drug product2013-09-1384e616aacf4f…
2026-09-14 22:38:342026-08N202317-00184503752026-03-07Drug product2013-09-1384e616aacf4f…
2026-09-14 22:38:342026-08N202317-00185018182026-03-07Drug product2013-09-1384e616aacf4f…
2026-09-14 22:38:342026-08N202317-00185018192026-03-07U-14272013-09-1384e616aacf4f…
2026-09-14 22:38:342026-08N202317-00193821912026-03-07Drug product2016-07-2684e616aacf4f…
2026-09-14 22:38:342026-08N202317-00178720502029-07-08U-14272013-09-1384e616aacf4f…
2026-08-18 06:07:402026-07N202317-00178385642026-03-07Drug product2013-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07N202317-00184503752026-03-07Drug product2013-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07N202317-00185018182026-03-07Drug product2013-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07N202317-00185018192026-03-07U-14272013-09-13caaa826d4ba7…
2026-08-18 06:07:402026-07N202317-00193821912026-03-07Drug product2016-07-26caaa826d4ba7…
2026-08-18 06:07:402026-07N202317-00178720502029-07-08U-14272013-09-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202317-00178385642026-03-07Drug product2013-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202317-00184503752026-03-07Drug product2013-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202317-00185018182026-03-07Drug product2013-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202317-00185018192026-03-07U-14272013-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202317-00193821912026-03-07Drug product2016-07-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N202317-00178720502029-07-08U-14272013-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202317-00178385642026-03-07Drug product2013-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202317-00184503752026-03-07Drug product2013-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202317-00185018182026-03-07Drug product2013-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202317-00185018192026-03-07U-14272013-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202317-00193821912026-03-07Drug product2016-07-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202317-00178720502029-07-08U-14272013-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08N202317-00178385642026-03-07Drug product2013-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202317-00184503752026-03-07Drug product2013-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202317-00185018182026-03-07Drug product2013-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202317-00185018192026-03-07U-14272013-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202317-00193821912026-03-07Drug product2016-07-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N202317-00178720502029-07-08U-14272013-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202317-00178385642026-03-07Drug product2013-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202317-00184503752026-03-07Drug product2013-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202317-00185018182026-03-07Drug product2013-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202317-00185018192026-03-07U-14272013-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202317-00193821912026-03-07Drug product2016-07-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202317-00178720502029-07-08U-14272013-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202317-00178385642026-03-07Drug product2013-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202317-00184503752026-03-07Drug product2013-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202317-00185018182026-03-07Drug product2013-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202317-00185018192026-03-07U-14272013-09-13b8a1b40f171c…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N202317-001ODE-512020-08-2374a2ff9319b5…
2020-12-22 03:56 UTC2020-12N202317-001ODE-512020-08-238869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202317-001ODE-512020-08-23c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202317-001ODE-512020-08-233f01610625f2…
2019-09-15 20:21 UTC2019-09N202317-001ODE-512020-08-23b00525d2431f…
2019-07-19 19:46 UTC2019-07N202317-001ODE-512020-08-23ea99ee380514…

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3e31b950-1f3d-4e3b-80c6-0bb7b7a8d54bad49e1df-e104-4e0e-9d6e-adb5f327d0e32018-12-13Exact identifier
spl id: 3e31b950-1f3d-4e3b-80c6-0bb7b7a8d54b
spl set id: ad49e1df-e104-4e0e-9d6e-adb5f327d0e3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.