possible Camphomex Spray Generic Name: camphor, histamine, menthol Dosage Form: topical spray 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. Camphomex Warnings For external use only. Use only as directed. Avoid contact with eyes and mucous membranes. Do not apply to open wounds or damaged skin. Do not use in combination with any external heat source. Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment. Consult physician for children under 12 years of age. Do not use if allergic to Camphor, Histamine, Menthol or any other components. Stop use and consult physician if symptoms worsen or persist for more than 7 days. Stop use if itching or excessive skin irritation occurs. If pregnant or breast feeding, contact physician prior to use. CAMPHOMEX TOPICAL SPRAY NDC: 69094-0229-04 ACTIVE INGREDIENTS: Camphor 4% Histamine 0.025% Menthol 10% INDICATIONS AND USAGE: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains. CLINICAL PHARMACOLOGY: Histamine works through vasodilation. This is the process of expanding blood vessels to increase circulation, providing pain relief within the affected tissue. Camphor is used topically to increase local blood flow and as a counterirritant. When applied externally, camphor numbs the nerve endings. The nerve endings then no longer transmit the sensation of pain. Menthol instantly brings cool, soothing pain relief to aching muscles. Menthol also has a natural analgesic attribute when applied topically. It has molecules called ligands, which attach themselves to receptors (Kappa Opioid Receptors) in your cell, which produces a numbing effect. Using Menthol topically causes vasodilation, which increases blood flow to the affected area, allowing other medicinal ingredients found in the topical spray to work faster. CONTRAINDICATIONS: Tetramex is contraindicated in patients with known history of hypersensitivity to local anesthetics, Menthol, camphor, and to other components of Tetramex topical spray. Directions: Adults and children 12 years and over apply directly to affected area. Do not use more than four times per day. Children under 12 years of age, consult a physician prior to use. Wash hands with soap before and after use. Avoid contact with eyes and mucous membranes. WARNING: -For external use only. Use only as directed. -Avoid contact with eyes and mucous membranes. -Do not apply to open wounds or damaged skin. -Do not use in combination with any external heat source. -Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment. -KEEP OUT OF REACH OF CHILDREN. Consult physician for children under 12 years of age. -Do not use if allergic to Menthol, Lidocaine, or any other components. -Stop use and consult physician if symptoms worsen or persist for more than 7 days. -Stop use if itching or excessive skin irritation occurs. -If pregnant or breast feeding, contact physician prior to use. Other Ingredients: Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia serrata extract, Dimethyl Sulfone, Emu Oil, Ethoxydiglycol, Glucosamine HCL, Glycrrhiza glabra (Licorice) Root Extract, PEG-40, Hydrogenated Castor Oil, Propylene Glycol (and) Diazolidinyl Urea (and) Iodopropynyl Butylcarbamate, SD Alcohol 40B. How Supplied: Mentholix is supplied in a 4 ounce (120ml) plastic bottle with a fine mist sprayer for topical application. Storage: Store at 20 to 25 C (68 to 77 F) [See USP Controlled Room Temperature]. Avoid direct sunlight. Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Dimethyl Sulfone, Emu Oil, Ethoxydiglycol, Glucosamine HCL, Glycrrhiza glabra (Licorice) Root Extract, PEG-40 Hydrogenated Castor Oil, Propylene Glycol (and) Diazolidinyl Urea (and) Lodopropynyl Butylcarbamate, SD Alcohol 40B, Fragrance. Apply directly to affected area. Do not use more than four times per day. Children under 12 years of age: Consult a Physician. Camphor............................4.0% Histamine DHCL................0.025% Menthol USP....................10.0% KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, strains, bruises and sprains. Store in 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature] CAMPHOMEX camphor, histamine, menthol spray Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69094-229 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 3.6 mg in 1 mL HISTAMINE (HISTAMINE) HISTAMINE 0.03 mg in 1 mL MENTHOL (MENTHOL) MENTHOL 12 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER ARNICA MONTANA FLOWER BOSWELLIA SERRATA WHOLE DIMETHYL SULFONE EMU OIL DIETHYLENE GLYCOL MONOETHYL ETHER GLUCOSAMINE HYDROCHLORIDE LICORICE CASTOR OIL PROPYLENE GLYCOL DIAZOLIDINYL UREA BUTYL CARBAMATE ALCOHOL Packaging # Item Code Package Description 1 NDC:69094-229-04 120 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/24/2014 Labeler - 1st Class Pharmaceuticals (079448685) Revised: 04/2015 1st Class 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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