BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE- bacitracin zinc, neomycin sulfate and polymyxin b sulfate 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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Triple Antibiotic Ointment

Active ingredient (in ea. gram)                                                Purpose           
Bacitracin Zinc 400 Units                                                          First Aid Antibiotic

Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin)              First Aid Antibiotic

Polymyxin B Sulfate 5000 Units                                                 First Aid 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

Inactive ingredients:

  • White petrolatum

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.

Warnings

For external use only

Dosage and Administration

  • clean the affected areas
  • apply a small amount of product (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

Do Not Use:

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • Stop use and ask a doctor if condition persists or gets worse, or if a rash or other allergic reaction occurs

Principal Display Panel

Sion Biotext Medical Ltd

Triple Antibiotic Ointment

SBM Triple.jpg

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BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-216
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68786-216-0572 in 1 CASE07/11/201212/31/2022
128.35 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68786-216-0112 in 1 CASE07/11/201212/31/2022
2144 in 1 BOX
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:68786-216-0312 in 1 CASE07/11/201212/31/2022
3144 in 1 BOX
30.5 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:68786-216-041728 in 1 CASE07/11/201212/31/2022
40.5 g in 1 PACKET; Type 0: Not a Combination Product
5NDC:68786-216-021728 in 1 CASE07/11/201212/31/2022
50.9 g in 1 PACKET; 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(68786-216)

Revised: 12/2022
 
Sion Biotext Medical Ltd