SINGLE 0.9G TRIPLE ANTIBIOTIC- bacitracin zinc 400 units ointment 
Sled Distribution, LLC

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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Ointment

Active ingredient

(in each gram)

Bacitracin Zinc (bacitracin 400 units)

Neoycin sulfate (neoycin 3.5 mg)

Polymyxin B sulfate

(polymyxin B 5,000 units)

Purpose

Bacitracin Zinc 400 units........First aid antibiotic

Uses

First aid to help prevent infection in

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 doctor

Ask a doctor before use if

  • on deep or puncture wounds, animal bites, or serious burns

Stop use and ask doctor if

  • 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

Inactive ingredients

Mineral oil, Petrolatum, Purified water

Principal Display Panel

OINTMENT

BoxLabel

SINGLE 0.9G TRIPLE ANTIBIOTIC 
bacitracin zinc 400 units ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.0035 g  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'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:81417-108-011 in 1 CARTON01/08/2021
10.9 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/08/2021
Labeler - Sled Distribution, LLC (079772888)
Establishment
NameAddressID/FEIBusiness Operations
Sled Distribution, LLC079772888manufacture(81417-108)

Revised: 1/2021
Document Id: 15b32098-15f8-4659-ad9d-4f7e951c236c
Set id: 2e03e7a8-e270-4a1f-9a54-8536ebe5c07b
Version: 10
Effective Time: 20210109
 
Sled Distribution, LLC