staff Valchlor Gel, Non-medicated Dosage Form: demonstration gel 1 Reference VALCHLOR US Prescribing Information. Instructions For Use 1 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. Print this page FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More photos
magnate Valchlor Gel, Non-medicated sports
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