BACITRACIN ZINC- bacitracin zinc ointment 
Sion Biotext Medical Ltd

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

Active Ingredient

Active ingredient                                            Purpose

Bacitracin Zinc (equal to 500 Bacitracin units)                 Antibiotic

Uses:

First aid to help prevent infection in:

  • Minor cuts
  • scrapes
  • burns

Ask a doctor before use:

  • in case of deep or puncture wounds
  • animal bites
  • serious burns

Other information

  • store at controlled room temperature 15°-30° C (59°-86° F)
  • Avoid excessive heat and humidity
  • tamper evident. Do not use if packet is torn, cut or open.

Inactive ingredients

Hard Paraffin, Liquid Paraffin, White Soft Paraffin

Directions

  • clean the affected area
  • apply a small amount of this product ( an equal amount 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

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.

Indications and Usage

  • First aid to help prevent infections
  • Not for ophthalmic use

Warnings

  • FOR EXTERNAL USE ONLY
  • Not for ophthalmic use.

Sion Biotext Medical Ltd

Bacitracin Zinc Ointment

SBM Bacitracin Zinc.jpg

Label

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68786-220-0272 in 1 CASE07/06/201212/31/2022
128.35 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68786-220-0112 in 1 CASE07/06/201212/31/2022
2144 in 1 BOX
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:68786-220-0372 in 1 CASE07/06/201212/31/2022
314.2 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:68786-220-0472 in 1 CASE07/06/201212/31/2022
4113.4 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:68786-220-0512 in 1 CASE07/06/201212/31/2022
5144 in 1 BOX
50.5 g in 1 PACKET; Type 0: Not a Combination Product
6NDC:68786-220-0672 in 1 CASE07/06/201212/31/2022
656.8 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:68786-220-0712 in 1 CASE07/06/201212/31/2022
7426 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/06/201212/31/2022
Labeler - Sion Biotext Medical Ltd (532775194)
Registrant - Sion Biotext Medical Ltd (532775194)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical Ltd532775194manufacture(68786-220)

Revised: 12/2022
Document Id: efe17a29-c448-d452-e053-2995a90ae9bd
Set id: 120f363b-c9d1-467d-b8d4-82c2023800eb
Version: 4
Effective Time: 20221215
 
Sion Biotext Medical Ltd