every body Silmanix Cream Generic Name: capsaicin, menthol, histamine dihydrochloride 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. PURPOSE: Topical analgesic ACTIVE INGREDIENTS Capsaicin 0.0357% --------------------------------------------------------------------------------------------------- Counterirritant Menthol 3% --------------------------------------------------------------------------------------------------------- Topical analgesic Histamine DiHydrochloride% ----------------------------------------------------------------------------------- Topical analgesic INDICATIONS For the temporary relief of minor pain of muscles and joints associated with: Arthritis Simple Backache Strains Sprains Bruises WARNINGS FOR EXTERNAL USE ONLY. Use only as directed Do not bandage tightly Do not use with a heating pad Avoid contact with the eyes or mucous membranes Do not apply to wounds, damaged, broken or irritated skin A transient burning sensation may occur upon application but generally disappears in several days If severe burning sensation occurs, discontinue use immediately and call a doctor Do not expose the area treated with product to heat or direct sunlight STOP USE AND ASK A DOCTOR IF: Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days Redness is present or irritation develops DIRECTIONS Adults and children over 18 years: Apply generously to affected area Massage into painful area until thoroughly absorbed into skin Repeat as necessary, not more than 3-4 times daily. Wash hands with soap and water immediately after use. Children 18 years or younger: ask a doctor Store at 20 -25 C (68 -77 F). Avoid direct sunlight. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222) If pregnant of breast-feeding, ask a healthcare professional before use INACTIVE INGREDIENTS aliphatic alcohol; stearic acid; vaseline; peregal; Carmellose; odium; water SIMANIX simanix pain relieving cream cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69379-013 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (CAPSAICIN) CAPSAICIN 0.0357 g in 100 g MENTHOL (MENTHOL) MENTHOL 3 g in 100 g HISTAMINE DIHYDROCHLORIDE (HISTAMINE) HISTAMINE DIHYDROCHLORIDE 0.035 g in 100 g Packaging # Item Code Package Description 1 NDC:69379-013-02 120 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/08/2015 Labeler - Home Aide Diagnostics, Inc. (783518983) Registrant - Zhejiang Bangli Medical Products Cl. Ltd (421295875) Establishment Name Address ID/FEI Operations Zhejiang Bangli Medical Products Co. Ltd 421295875 manufacture(69379-013) Revised: 07/2015 Home Aide Diagnostics, Inc. 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 without boundary lines
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