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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drug facts

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

USE

First aid to help prevent infection in

minor cuts
scrapes
burns

Warning

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

Clean the affected area
Apply a small amount of this product (an amount equal 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

Store at room temperature

Inactive ingredients

Mineral oil, Petrolatum, Purified water

label image

0.9G TRIPLE ANTIBIOTIC 
bacitracin zinc 400 units ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-128
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [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:81417-128-011 in 1 PACKAGE03/24/2022
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 finalpart333B03/24/2022
Labeler - Sled Distribution, LLC (079772888)
Establishment
NameAddressID/FEIBusiness Operations
Sled Distribution, LLC079772888manufacture(81417-128)

Revised: 3/2022
Document Id: 14a25e81-deff-48af-a077-c8c685bddbd8
Set id: fa4eee0a-a6ca-4356-b8f5-7e03294a7be6
Version: 1
Effective Time: 20220324
 
Sled Distribution, LLC