Country: United States
Language: English
Source: NLM (National Library of Medicine)
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES)
H.J. Harkins Company, Inc.
Bacitracin Zinc
Bacitracin Zinc 500 [USP'U] in 1 g
TOPICAL
OTC DRUG
Antibiotic 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 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 if a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 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 covered with a sterile bandage Other information store at room temperature Inactive ingredient white petrolatum
OTC monograph final
BACITRACIN ZINC - BACITRACIN ZINC OINTMENT H.J. HARKINS COMPANY, INC. _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 USP DRUG FACTS ACTIVE INGREDIENTS (IN EACH GRAM) Bacitracin Zinc (equal to 500 bacitracin units) PURPOS E Antibiotic 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 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 if a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. _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 covered with a sterile bandage _OTHER INFORMATION_ store at room temperature _Inactive ingredient_ white petrolatum E. FOUGERA AND CO. a division of Nycomed US Inc. MELVILLE, NEW YORK 11747 Repacked by: H.J. Harkins Company Inc. Nipomo, CA 93444 BACITRACIN ZINC bacitracin zinc ointment PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:529 59 -113(NDC:0 16 8 -0 0 11) ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH BA CITRA CIN ZINC (UNII: 8 9 Y4M234ES) (Bacitracin Zinc - UNII:8 9 Y4M234ES) Bacitracin Zinc 50 0 [USP'U] in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH PETRO LA TUM (UNII: 4T6 H12BN9 U) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:529 59 -113-0 3 28 .34 g in 1 TUBE 2 NDC:529 59 -113-15 14.17 g i Read the complete document