PATIENT PACKAGE INSERT IN ACCORDANCE 2. BEFORE USING THE MEDICINE: Directions for use: Apply a thin layer on the achy 5. HOW SHOULD THE MEDICINE BE WITH THE PHARMACISTS’ REGULATIONS area only and gently massage until the cream STORED? (PREPARATIONS) - 1986 Do not use this medicine: disappears (is absorbed). • if you are sensitive (allergic) to the active • Avoid poisoning! This medicine and any other This medicine is dispensed ingredients or to any of the other ingredients Do not exceed the recommended dose. medicine must be kept in a safe place out of without a doctor’s prescription contained in the medicine. Do not swallow! For external use only. the of children and/or infants to avoid • If there is no improvement in your condition within poisoning. Do not induce vomiting without on damaged skin or on sores. explicit instruction from the doctor. ® • 10 days, refer to a doctor. in children and infants under 12 years of age, • Do not use the medicine after the expiry date BenGay Greaseless without a doctor’s instructions. If you took an overdose, or if a child accidentally swallowed the medicine, immediately refer to a (exp. date) that appears on the package. The Pain Relieving Cream Special warnings regarding use of the doctor or proceed to a hospital emergency room expiry date refers to the last day of that month. Cream medicine and bring the package of the medicine with you. • Store in a cool place between 20-25°C. • Excessive use may result in salicylate toxicity Do not take medicines in the dark! Check the • Store in the original package. Do not store Active ingredients - each unit contains: (salicylates have been associated with Reye’s label and dose each time you take medicine. Wear different medicines in the same package. 15% syndrome). glasses if you need them. 6. FURTHER INFORMATION 10% • Do not use with a heating pad or bandage with If you have further questions regarding use of the tight dressing. medicine, consult the doctor or pharmacist. In addition to the active ingredients, the medicine also contains: ® • Avoid contact of the preparation with the eyes. In BenGay Ultra Strength case of contact, wash immediately with water. 4. SIDE EFFECTS - BenGay Greaseless Pain Relieving Cream: • Avoid contact of the preparation with mucosal As with any medicine, use of BenGay may cause Xanthan Gum, Methylparaben, Propylparaben, Cream tissues (e.g., the mouth and nose). side effects in some users. Do not be alarmed Glycerin, Isopropyl Palmitate, Stearic acid, Cetyl when reading the list of side effects. You may not Active ingredients - each unit contains: • If hyperirritation occurs, stop use. See section 4 Alcohol, Glyceryl Stearate V, Potassium Cetyl experience any of them. Phosphate, Potassium Hydroxide, Purified Methyl Salicylate 30% “Side Effects”. Discontinue use and refer to a doctor as soon Water, Phenoxyethanol. Menthol 10% Before treatment with BenGay, tell the doctor - BenGay Ultra Strength: Camphor 4% if: as possible, if the following occur: • • Irritation (rare) Carbomer, Stearic acid, Glyceryl Stearate SE, you are sensitive to any food or medicine, Tween 80 (Polysorbate 80), Lanolin, Trolamine, Inactive ingredients and allergens: see section 6 especially to salicylates. • Rash (rare) “Further Information”. • Potassium Hydroxide, Edetate Disodium, Purified • you use this medicine frequently or for a prolonged Local inflammation (rare) Water. Read this leaflet carefully in its entirety before period. Additional side effects using this medicine. This leaflet contains concise What the medicine looks like and the contents information about the medicine. If you have further If you are taking, or have recently taken, other Occurring rarely: of the package: questions, refer to the doctor or pharmacist. medicines, including non-prescription medicines • Eyes: ocular irritation - BenGay Greaseless Pain Relieving Cream: and nutritional supplements, tell the doctor The medicine is not intended for conditions similar • Immune system disorders: angioedema A plastic tube 2 OZ. or pharmacist. Especially inform the doctor or • Respiratory system: shortness of breath to arthritis in infants and children under 12 years of pharmacist if you are taking: - BenGay Ultra Strength: age. Under this age, refer to a doctor. (associated with hypersensitivity) A plastic tube 2 OZ, 4 OZ, 6 OZ. • other preparations containing salicylates (e.g., • Application site: skin edema, blisters, burning Use correctly. Consult a pharmacist if you need aspirin): concomitant use may lead to salicylate Not all pack sizes may be marketed. further information. Refer to the doctor if the signs sensation, redness, irritation, pain, tingling, poisoning. itching, and rash. In addition, urticaria, cold Registration Holder and address: of the disease (symptoms) worsen or if they do not • improve after 10 days. anticoagulants, such as Coumadin: the sensation (BenGay Ultra Strength) J-C Health Care Ltd., Kibbutz Shefayim 6099000, combination may increase the potential for • Application site sores or toxicity: burns Israel. 1. WHAT IS THIS MEDICINE INTENDED FOR? bleeding, since BenGay contains salicylate. If a side effect occurs, if any of the side effects Manufacturer and address: Pregnancy and breastfeeding This medicine is indicated for the temporary relief of worsen, if you suffer from a side effect not Johnson & Johnson Consumer Inc., NJ, USA. minor aches and pains of muscles and joints, such There is not enough information for safe use mentioned in this leaflet, or if there is a change in as simple back ache, lumbago, arthritis, strains, during pregnancy or breastfeeding. Use during your general feeling, consult the doctor. The format of this leaflet was determined by the bruises and sprains. pregnancy and/or breastfeeding must be under Ministry of Health and its content was checked medical supervision. Reporting side effects and approved in July 2014. Therapeutic group: Methyl salicylate belongs Side effects can be reported to the Ministry of to the salicylates group, which are non-steroidal Driving and use of machinery Health by clicking on the link “Report Side Effects Registration number of the medicine in the National anti-inflammatory agents. This medicine has no effect on ability to drive or of Drug Treatment” found on the Ministry of Health Drug Registry of the Ministry of Health: operate machines. homepage (www.health.gov.il) that directs you to - BenGay Greaseless Pain Relieving Cream: the online form for reporting side effects, 133-96-23330-00 3. HOW SHOULD THE MEDICINE be USEd? or by entering the link: - BenGay Ultra Strength: Check with the doctor or pharmacist if you are https://forms.gov.il/globaldata/getsequence/getse 133-94-27518-00 uncertain. The usual dosage is generally: quence.aspx?formType=AdversEffectMedic@moh. Apply 3-4 times a day, as needed. gov.il SH Z203000309999B/BNG MAR19 SH Z203000309999B/BNG MAR19