Country: United States
Language: English
Source: NLM (National Library of Medicine)
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)
Cardinal Health
NEOMYCIN SULFATE
NEOMYCIN 3.5 mg
OTC DRUG
OTC monograph final
TRIPLE ANTIBIOTIC- NEOMYCIN, POLYMYXIN B SULFATES, BACITRACIN OINTMENT CARDINAL HEALTH _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._ ---------- TRIPLE ANTIBIOTIC OINTMENT ACTIVE INGREDIENT In each Gram: Neomycin Sulfate (equivalent to 3.5 mg neomycin base) Polymyxin B Sulfate (equal to 5,000 polymyxin B units) Bacitracin Zinc (equal to 400 bacitracin units) PURPOS E Antibiotic KEEP OUT OF REACH OF CHILDREN Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away. US ES First aid to help prevent infection in minor cuts, scrapes and burns WARNINGS For external use only. This package is intended for institutional use only. Do not use in the eyes, over large areas of the body or if you are allergic to any of the ingredients. Ask a doctor before use in case of deep or puncture wounds, animal bites or serious burns. When using this product do not use longer than 1 week unless directed by a doctor. Stop use and ask a doctor if the condition persists or gets worse or if a rash or other allergic reaction develops. DIRECTIONS Clean the affected area, apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily, may be coved with a sterile bandage INACTIVE INGREDIENTS White petrolatum STORAGE Store at Room Temperature E. FOUGERA & CO. a division of Nycomed US Inc., MELVILLE, NEW YORK 11747 Questions or comments? call toll free 1-800-645-9833 Repackaged by Cardinal Health Zanesville, OH 43701 PRINCIPAL DISPLAY PANEL Triple Antibiotic Ointment Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP First Aid Antibiotic 6-Foilpacs Net Wt. 0.9 G (1/32 Oz) TRIPLE ANTIBIOTIC neomycin, polymyxin b sulfates, bacitracin ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:55154-0 156 (NDC:0 16 8 -0 0 12) ROUTE OF Read the complete document