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Bacitracin Zinc by Sion Biotext Medical Ltd

Medically reviewed on July 6, 2017

Dosage form: ointment
Ingredients: BACITRACIN ZINC 500[iU] in 1g
Labeler: Sion Biotext Medical Ltd
NDC Code: 68786-220

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.

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

BACITRACIN ZINC 
bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-220
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN ZINC) BACITRACIN ZINC500 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
LIGHT MINERAL OIL 
MINERAL OIL 
Packaging
#Item CodePackage Description
1NDC:68786-220-0272 TUBE (TUBE) in 1 CASE
128.35 g in 1 TUBE
2NDC:68786-220-0112 BOX (BOX) in 1 CASE
2144 PACKET (PACKET) in 1 BOX
20.9 g in 1 PACKET
3NDC:68786-220-0372 TUBE (TUBE) in 1 CASE
314.2 g in 1 TUBE
4NDC:68786-220-0472 TUBE (TUBE) in 1 CASE
4113.4 g in 1 TUBE
5NDC:68786-220-0512 BOX (BOX) in 1 CASE
5144 PACKET (PACKET) in 1 BOX
50.5 g in 1 PACKET
6NDC:68786-220-0672 TUBE (TUBE) in 1 CASE
656.8 g in 1 TUBE
7NDC:68786-220-0712 JAR (JAR) in 1 CASE
7426 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/06/2012
Labeler - Sion Biotext Medical Ltd (532775194)
Establishment
NameAddressID/FEIOperations
Sion Biotext Medical Ltd532775194manufacture

 
Sion Biotext Medical Ltd

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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