国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)
Lincoln Pharmaceuticals Ltd.
TOPICAL
OTC DRUG
OTC monograph final
LINCOLN- BACITRACIN ZINC OINTMENT LINCOLN PHARMACEUTICALS LTD. _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._ ---------- DRUG FACTS Active Ingredient (in each gram) Bacitracin Zinc (equal to 500 bacitracin units) DRUG FACTS First Aid Antibiotic DRUG FACTS Uses first aid to help prevent infection in minor cuts scrapes burns DRUG FACTS For External use only DO NOT USE in the eyes if you are allergenic to any of the ingredients over large area of the body longer than 1 week unless directed by a doctor DRUG FACTS deep or puncture wounds animal bites serious burns DRUG FACTS the condition persists or get worse a rash or other allergic reaction develops DRUG FACTS Keep out of reach of children if swallowed, get medical help or Contact a Poison Control Center right away DRUG FACTS clean the affected area apply a small amount of this product (an amount equals 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 DRUG FACTS OTHER INFORMATION: store at controlled temperature 15°-30° C Avoid excessive heat and humidity DRUG FACTS Inactive ingredients hard paraffin, liquid paraffin, white soft paraffin, lanolin PRINCIPAL DISPLAY PANEL LINCOLN bacitracin zinc ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 9 6 36 -30 35 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I) BACITRACIN 50 0 [USP'U] in 1 g Lincoln Pharmaceuticals Ltd. INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH MINERAL O IL (UNII: T5L8 T28 FGP) LANO LIN (UNII: 7EV6 5EAW6 H) PETRO LATUM (UNII: 4T6 H12BN9 U) PARAFFIN (UNII: I9 O0 E3H2ZE) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:6 9 6 36 -30 35-2 0 .9 g in 1 PACKET; Type 0 : No t a Co mb 阅读完整的文件