any one Validerm Cream Generic Name: calcitriol, fluticasone propionate and tacrolimus Dosage Form: cream Print this page Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. VALIDERM Cream (Calcitriol USP, Fluticasone Propionate USP, Tacrolimus USP) Topical Cream (as dispensed): Calcitriol 2mcg/gm, Fluticasone Propionate 0.05%, Tacrolimus 0.05% For Dermatological Use Only Not for Ophthalmic Use * MUST RECONSTITUTE BEFORE DISPENSING * Rx Only 69167-1025-09 Validerm Cream Description VALIDERM is comprised of 0.2 mg of Calcitriol USP, 50 mg of Fluticasone Propionate USP, and 50 mg of Tacrolimus USP for dermatological use. 1 VALIDERM also contains a Cream Base containing purified water, white petrolatum, sorbitol solution, cetearyl alcohol, propylene glycol, ceteareth-20, simethicone, glyceryl monostearate, polyethylene glycol monostearate, sorbic acid and BHT. When mixed as instructed, the final product provides a homogeneous cream mixture containing Calcitriol, Fluticasone Propionate and Tacrolimus comparable to the active ingredients (Vectical 3mcg/g, Cutivate 0.05%, and Protopic 0.1%) contained in VALIDERM . 2 1 Certificate of analysis on file 2 This product is not manufactured by Galderma Labs LP, manufacturer of Vectical , GlaxoSmithKline, manufacturer of Cutivate , or by Astellas Pharma US, Inc., manufacturer of Protopic . Validerm Cream Dosage and Administration The pharmacist must mix contents of each container with appropriate amount of Cream Base yielding a final volume of 100 grams at the time of dispensing. Pharmacist may utilize appropriate diluents if needed from the respective active component Material Safety Data Sheet only. For dermatological use only. This product should not be administered orally. Contraindications VALIDERM Topical Cream, as dispensed, is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. USES Consult your pharmacist. HOW TO USE Consult your pharmacist. Precautions Consult your pharmacist. Drug Interactions Consult your pharmacist. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. SIDE EFFECTS Consult your pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. MISSED DOSE Consult your pharmacist. NOTES No Monograph available at this time. How is Validerm Cream Supplied VALIDERM Cream, as dispensed, is supplied as a five component package: three containers which contain the active components Calcitriol USP 0.2 mg, Fluticasone Propionate USP 50 mg, and Tacrolimus USP 50 mg (respectively), a separate package of Cream Base and a stirring apparatus. The pharmacist must mix contents of each active component container with appropriate amount of Cream Base such that the QS volume yields 100 grams (final weight) at the time of dispensing. Pharmacist may utilize appropriate diluents if needed from the respective active component Material Safety Data Sheet only. Pharmacist must only use appropriate amount of Cream Base such that the final volume yields 100 grams inclusive of all drug substances, any diluents that may have been added, and Cream Base. Pharmacist may dispense final product upon reconstituting and mixing into a dispensing container of their choice or as directed by prescriber. Mix for 5 minutes before dispensing. May use mixing aid, if necessary. Shake well before using. Store between 15 and 30 C (59 and 86 F) in tightly closed containers prior to mixing. Store final product at refrigerated temperature, 2 -8 C (36 -46 F). For dermatological use only. Avoid contact with eyes. Keep container tightly closed. Keep out of the reach of children. Protect from light. Protect from freezing. VALIDERM Cream, as dispensed, is stable for at least 30 days at refrigerated temperature upon mixing as recommended under USP 795 Guidelines. U.S. Patent Pending Distributed By: Accumix Pharmaceuticals East Windsor, NJ 08520 Issued: October 2014 v1 Rx ONLY For External Use Only PRINCIPAL DISPLAY PANEL - NDC: 69167-1025-9 - Carton Label VALIDERM calcitriol, fluticasone propionate and tacrolimus kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69167-1025 Packaging # Item Code Package Description 1 NDC:69167-1025-9 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 PACKAGE 0.2 mg Part 2 1 PACKAGE 0.05 g Part 3 1 PACKAGE 0.05 g Part 4 1 BOTTLE 113 g Part 1 of 4 CALCITRIOL calcitriol powder, for suspension Product Information Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALCITRIOL (CALCITRIOL) CALCITRIOL 0.2 mg in 0.2 mg Packaging # Item Code Package Description 1 0.2 mg in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/15/2014 Part 2 of 4 FLUTICASONE PROPIONATE fluticasone propionate powder, for suspension Product Information Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUTICASONE PROPIONATE (FLUTICASONE) FLUTICASONE PROPIONATE 0.05 g in 0.05 g Packaging # Item Code Package Description 1 0.05 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/15/2014 Part 3 of 4 TACROLIMUS tacrolimus powder, for suspension Product Information Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TACROLIMUS (TACROLIMUS ANHYDROUS) TACROLIMUS ANHYDROUS 0.05 g in 0.05 g Packaging # Item Code Package Description 1 0.05 g in 1 PACKAGE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/15/2014 Part 4 of 4 CREAM BASE cream cream Product Information Route of Administration TOPICAL DEA Schedule Inactive Ingredients Ingredient Name Strength WATER PETROLATUM SORBITOL CETOSTEARYL ALCOHOL PROPYLENE GLYCOL POLYOXYL 20 CETOSTEARYL ETHER DIMETHICONE GLYCERYL MONOSTEARATE POLYETHYLENE GLYCOLS SORBIC ACID BUTYLATED HYDROXYTOLUENE Packaging # Item Code Package Description 1 113 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/15/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 12/15/2014 Labeler - Accumix Pharmaceuticals (079460461) Revised: 01/2015 Accumix Pharmaceuticals 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... 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the correct Validerm Cream to intensify
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