ASTONEA FIRST AID- bacitracin zinc ointment 
ASTONEA LABS 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.

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ASTONEA 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, due to possibility of anaphylactic shock ■ 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 and Drug Fact Panel

ASTONEA  FIRST AID
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-303
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:77338-303-520.9 g in 1 PACKET; Type 0: Not a Combination Product05/02/2022
2NDC:77338-303-5328.3 g in 1 TUBE; Type 0: Not a Combination Product05/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B05/02/2022
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)
Establishment
NameAddressID/FEIBusiness Operations
ASTONEA LABS PRIVATE LIMITED878533295manufacture(77338-303)

Revised: 8/2022
Document Id: e689c2dd-182b-5d1c-e053-2a95a90a9bcc
Set id: de0b2e06-64bc-78f0-e053-2995a90a39a0
Version: 2
Effective Time: 20220818
 
ASTONEA LABS PRIVATE LIMITED