ANCALIMA BACITRACIN ZINC FIRST AID- bacitracin zinc ointment 
ANCALIMA LIFESCIENCES 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.

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ANCALIMA Bacitracin Zinc

Active Ingredient (in each gram)

Bacitracin Zinc (equal to 500 bacitracin 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

■ Not for opthalmic use 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 ■ serious burns

Stop use and ask a doctor if

■ the condition persists or gets worse

■ a rash or other allergic reaction develops

Keep out of reach of children

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 15-30C (59-86F)

■ avoid excessive heat and humidity

Inactive Ingredients

hard paraffin, liquid paraffin, white soft paraffin, lanolin

Package Label

Principal Display & Drug Fact Panel

ANCALIMA BACITRACIN ZINC  FIRST AID
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73014-3035
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
PARAFFIN (UNII: I9O0E3H2ZE)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73014-3035-20.9 g in 1 PACKET; Type 0: Not a Combination Product04/08/2019
2NDC:73014-3035-314 g in 1 TUBE; Type 0: Not a Combination Product04/08/2019
3NDC:73014-3035-428 g in 1 TUBE; Type 0: Not a Combination Product04/08/2019
4NDC:73014-3035-5113 g in 1 TUBE; Type 0: Not a Combination Product04/08/2019
5NDC:73014-3035-6425 g in 1 JAR; Type 0: Not a Combination Product04/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/08/2019
Labeler - ANCALIMA LIFESCIENCES LIMITED (676760093)

Revised: 1/2021
Document Id: b8b4d183-ee7a-4c28-e053-2995a90a4c5f
Set id: 860f9a5f-71f3-4be4-e053-2991aa0ae617
Version: 2
Effective Time: 20210112
 
ANCALIMA LIFESCIENCES LIMITED