BACITRACIN- bacitracin 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 Ointment

Active Ingredient

Active ingredient               Purpose

Bacitracin 500 Units                Antibiotic

Uses:

First aid to help prevent infection in:

  • Minor cuts
  • scrapes
  • burns

Warnings:

  • FOR EXTERNAL USE ONLY
  • 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.

Other information

  • store at controlled room temperature 15°-30° C (59°-86° F)

Inactive ingredients

Light Mineral Oil, White Petrolatum

Indications and Usage

  • clean the affected areas
  • apply a small amount (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Stop Use

Stop use and ask a doctor if:

  • if condition persist 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.

Dosage and Administration


  • Do not use over large areas of the body, longer than 1 week unless directed by a doctor
  • apply a small amount (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily

Principal Display Panel

NDC 68786-218-01/02/03/04/05/06/07

BACITRACIN OINTMENT

FIRST AID ANTIBIOTIC

NET WT 1 oz. (28.4 g)

Label

BACITRACIN 
bacitracin ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-218
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68786-218-0112 in 1 CASE07/09/201212/31/2022
1144 in 1 BOX
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:68786-218-0372 in 1 CASE07/09/201212/31/2022
214.17 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:68786-218-0472 in 1 CASE07/09/201212/31/2022
328.35 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:68786-218-0212 in 1 CASE07/09/201212/31/2022
4144 in 1 BOX
40.5 g in 1 PACKET; Type 0: Not a Combination Product
5NDC:68786-218-0572 in 1 CASE07/09/201212/31/2022
556.8 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:68786-218-0672 in 1 CASE07/09/201212/31/2022
6113.6 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:68786-218-0712 in 1 CASE07/09/201212/31/2022
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 finalpart333B07/09/201212/31/2022
Labeler - Sion Biotext Medical Ltd (532775194)
Registrant - Sion Biotext Medical Ltd (532775194)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical Ltd532775194manufacture(68786-218)

Revised: 12/2022
 
Sion Biotext Medical Ltd