Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)
Trifecta Pharmaceuticals USA LLC
TOPICAL
OTC DRUG
First Aid Antibiotic First Aid Antibiotic First Aid Antibiotic First Aid to help prevent infection in minor: - cuts - scrapes - burns deep or puncture wounds animal bites serious burns - in eyes - over large areas of the body - if you are allergic to any of the ingredients - If you need to use longer than 1 week - The condition persists or gets worse - A rash or allergic reaction develops
OTC monograph final
TRIPLE ANTIBIOTIC- BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE OINTMENT TRIFECTA PHARMACEUTICALS USA LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- GLOBE TRIPLE ANTIBIOTIC OINTMENT ACTIVE INGREDIENT Bacitracin Zinc 400 Units PURPOSE First Aid Antibiotic ACTIVE INGREDIENT Neomycin 3.5 mg PURPOSE First Aid Antibiotic ACTIVE INGREDIENT Polymyxin B Sulfate 5000 Units PURPOSE First Aid Antibiotic USES First Aid to help prevent infection in minor: cuts scrapes burns WARNINGS FOR EXTERNAL USE ONLY. ASK DOCTOR BEFORE USE IF YOU HAVE deep or puncture wounds animal bites serious burns DO NOT USE in eyes over large areas of the body if you are allergic to any of the ingredients STOP USE AND ASK DOCTOR IF If you need to use longer than 1 week The condition persists or gets worse A rash or allergic reaction develops DIRECTIONS Clean the affected area and dry thoroughly Apply a small amount of the product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily May be covered with a sterile bandage INACTIVE INGREDIENTS mineral oil and petrolatum QUESTIONS Call 1-888-296-9067 Fax: 1-888-878-3609 Online: www.trifecta-pharma.com Reorder No. 1012SL STORAGE INFORMATION Store at 20° to 25°C (68° to 77°F). KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center immediately. OTHER INFORMATION Distributed By: Trifecta Pharmaceuticals USA® Ft. Lauderdale, FL. 33301 USA Made in USA PACKAGING TRIPLE ANTIBIOTIC bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment Trifecta Pharmaceuticals USA LLC PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:69396-062 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ 07J96K) POLYMYXIN B 50 Læs hele dokumentet