Country: United States
Language: English
Source: NLM (National Library of Medicine)
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)
Galentic Pharma (India) Private Limited
Bacitracin Zinc
Bacitracin 500 [iU] in 1 g
TOPICAL
OTC DRUG
First Aid Antibiotic First aid to help prevent infection in - minor cuts - scrapes - burns
OTC monograph final
BACITRACIN ZINC- BACITRACIN ZINC OINTMENT GALENTIC PHARMA (INDIA) PRIVATE LIMITED _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._ ---------- BACITRACIN ZINC OINTMENT • ACTIVE INGREDIENT Active Ingredient (each gram contains) Bacitracin Zinc 500 units • PURPOSE First Aid Antibiotic • USES First aid to help prevent infection in minor cuts scrapes burns • WARNINGS FOR EXTERNAL USE ONLY DO NOT USE: In the eyes if you are allergic to any of the ingredients over large areas of the body longer than 1 week unless directed by a doctor • ASK A DOCTOR BEFORE USE in case of deep or puncture wounds, animal bites, or serious burns • STOP USE AND ASK A DOCTOR IF condition persists or gets worse rash or other allergic reaction develops • KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center immediately. • DIRECTIONS Clean the affected area Apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily May be covered with a sterile bandage • OTHER INFORMATION Store at 15° to 30°C (59° to 86°F) Lot No. & Exp. Date. See box or crimp of tube. • INACTIVE INGREDIENT Hard Paraffin, Liquid Paraffin, White Soft Paraffin Manufactured by : GALENTIC PHARMA (INDIA) PVT. LTD., Plot No. 5-B & 5-C, Sector III, Kandla Special Economic Zone, Gandhidham-370 230, Gujarat. India PRINCIPAL DISPLAY PANEL - 28 G TUBE CARTON GALENTIC BACITRACIN OINTMENT _FIRST AID ANTIBIOTIC_ BACITRACIN ZINC _HELPS TO HEAL BURNS, SCRAPES & CUTS _ _PREVENTS INFECTIONS_ NET WT. 1 OZ. (28G) BACITRACIN ZINC bacitracin zinc ointment PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:50382-006 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BA Read the complete document