GENUINE FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate cream 
GFA Production(Xiamen) Co.,Ltd

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Genuine First Aid Antibiotic Ointment

Drug Facts

Active ingredients (in each gram)

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

First aid antibiotic

Use 

First aid to help prevent infection in minor cuts, scrapes, and 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
  • longer than 1 week unless directed by a doctor.

Ask a doctor before use if you have 

  • deep or puncture wounds
  • animal bites
  • serious bums

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Store at room temperature

Inactive ingredients 

Mineral oil, petrolatum, purified water

Package Labeling:

Label02

GENUINE FIRST AID ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50814-077
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50814-077-010.9 g in 1 TUBE; Type 0: Not a Combination Product11/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00411/01/2023
Labeler - GFA Production(Xiamen) Co.,Ltd (421256261)

Revised: 11/2023
Document Id: 0aaeaa08-d664-cb12-e063-6394a90a9163
Set id: 0aaee474-cf35-8b39-e063-6294a90a815c
Version: 1
Effective Time: 20231121
 
GFA Production(Xiamen) Co.,Ltd