Country: United States
Language: English
Source: NLM (National Library of Medicine)
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I), NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
Chain Drug Marketing Association
TOPICAL
OTC DRUG
First Aid Antibiotic Ointment Uses first aid to help prevent infection in minor:● cuts ● scrapes ● burns - In the eyes - Over large areas of the body - If you are allergic to any of the ingredients - Condition persists or gets worse - You need to use longer than 1 week - A rash or other allergic reaction develops - Deep or puncture wounds - Animal bites - Serious burns
OTC monograph final
TRIPLE ANTIBIOTIC- BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. OINTMENT CHAIN DRUG MARKETING ASSOCIATION _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 FIRST AID ANTIBIOTIC DRUG FACTS _ACTIVE INGREDIENTS (EACH GRAM CONTAINS)_ Bacitracin zinc 400 units Neomycin sulfate 3.5 mg Polymyxin B sulfate 5,000 units _PURPOSE_ First Aid Antibiotic Ointment USES first aid to help prevent infection in minor:● cuts ● scrapes ● burns _WARNINGS_ FOR EXTERNAL USE ONLY. DO NOT USE In the eyes Over large areas of the body If you are allergic to any of the ingredients STOP USE AND ASK A DOCTOR IF Condition persists or gets worse You need to use longer than 1 week A rash or other allergic reaction develops ASK DOCTOR BEFORE USE IF YOU HAVE Deep or puncture wounds Animal bites Serious burns KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. _DIRECTIONS_ ● clean the affected area and dry thoroughly. ● 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 covered with a sterile bandage. _OTHER INFORMATION_ ● To open: unscrew cap, pull tab to remove foil seal ● store at 20° to 25°C ( 68° to 77°F) ● see carton or tube crimp for lot number and expiration date. _INACTIVE INGREDIENT_Mineral Oil, Petrolatum DISTRIBUTED BY C.D.M.A., INC. © 43157 W 9 Mile Rd. Novi, MI. 48375 www.qualitychoice.com Questions: 800-935-2362 OTHER INFORMATION: This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Neosporin® PACKAGING TRIPLE ANTIBIOTIC bacitracin zinc, neomycin sulfate , polymyxin b sulfate. ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:63868-459 ROUTE OF ADMINISTRATION TOPICAL Chain Read the complete document