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Valchlor Gel, Non-medicated

Dosage Form: demonstration gel

1
Reference VALCHLOR US Prescribing Information.

Instructions For Use1

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.

ACT20150424

1
Reference VALCHLOR US Prescribing Information.

PRINCIPAL DISPLAY PANEL - 5 g Tube Carton

Non-medicated VALCHLOR®

Demonstration Gel

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

NON-MEDICATED VALCHLOR DEMONSTRATION 
non-medicated valchlor demonstration gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:66215-001
Route of Administration TOPICAL DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
diethylene glycol monoethyl ether 2.4965 g  in 5 g
propylene glycol 0.8785 g  in 5 g
isopropyl alcohol 0.7635 g  in 5 g
glycerin 0.5665 g  in 5 g
lactic acid 0.1825 g  in 5 g
hydroxypropyl cellulose (type h) 0.1 g  in 5 g
sodium chloride 0.009 g  in 5 g
Racementhol 0.0025 g  in 5 g
edetate disodium 0.0005 g  in 5 g
butylated hydroxytoluene 0.0005 g  in 5 g
Product Characteristics
Color WHITE (CLEAR) Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:66215-001-05 1 TUBE in 1 CARTON
1 5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202317 01/13/2016
Labeler - Actelion Pharmaceuticals US, Inc. (002641228)
Registrant - Actelion Pharmaceuticals, Ltd. (480007868)
Establishment
Name Address ID/FEI Operations
Frontage Laboratories, Inc. 826782653 ANALYSIS(66215-001)
Establishment
Name Address ID/FEI Operations
University of Iowa Pharmaceuticals 968859939 ANALYSIS(66215-001), LABEL(66215-001), MANUFACTURE(66215-001), PACK(66215-001)
Establishment
Name Address ID/FEI Operations
University of Iowa Pharmaceuticals 968854286 ANALYSIS(66215-001)
Establishment
Name Address ID/FEI Operations
Packaging Coordinators Inc. 098908572 PACK(66215-001)
Establishment
Name Address ID/FEI Operations
Packaging Coordinators Inc. 762771269 PACK(66215-001)
Establishment
Name Address ID/FEI Operations
Actelion Pharmaceuticals, Ltd. 480007868 ANALYSIS(66215-001)
Revised: 11/2015
 
Actelion Pharmaceuticals US, Inc.



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