Bacitracin Zinc Ointment_OTC

Bacitracin Zinc by

Drug Labeling and Warnings

Bacitracin Zinc by is a Otc medication manufactured, distributed, or labeled by A-S Medication Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BACITRACIN ZINC- bacitracin zinc ointment 
A-S Medication Solutions

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.

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Bacitracin Zinc Ointment_OTC

ACTIVE INGREDIENT (in each gram)

Bacitracin zinc, USP 500 units

PURPOSE

First aid antibiotic

USES

First aid to help prevent infection in   minor cuts   scrapes   burns

WARNINGS

For external use only

ALLERGY ALERT:   do not use if allergic to any of the ingredients

DO NOT USE    in the eyes   over large areas of the body

ASK A DOCTOR BEFORE USE IF YOU HAVE   deep or puncture wounds   animal bites  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    condition persists or gets worse   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 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 59°-77°F (15°-25°C).   Before using any medication, read all label directions.  Keep carton, it contains important information.

INACTIVE INGREDIENT    white petrolatum

QUESTIONS?    1-800-432-8534 between 9 am and 4 pm EST, Monday–Friday.

HOW SUPPLIED

Product: 50090-3279

Storage

Store at room temperature 59°-77°F (15°-25°C). Before using any medication, read all label directions. Keep carton, it contains important information.

bacitracin zinc

Label Image
BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 50090-3279(NDC: 0472-1105)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 50090-3279-01 in 1 CARTON11/22/201706/30/2019
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333B06/01/199706/30/2019
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-3279)

Revised: 1/2020
Document Id: 7b82d19f-610a-4caa-a876-4f5beaf33aea
Set id: a21bcaf1-3b3a-44de-98e4-f2e0d235ae05
Version: 7
Effective Time: 20200118