TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b ointment 
Kareway Product, Inc.

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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Soundbody Triple Antibiotic Ointment

Active ingredient

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection in minor:

Warnings

For external use only.

Do not use

  • If you are allergic to any of the ingredients

When using this product

  • do not use in the eyes
  • do not apply over large areas of the body

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • 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

cetyl alcohol, mineral oil, petrolatum, squalane, stearic acid, tocopheryl acetate

Package label panel

Triple Antibiotic Ointment

carton

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0631
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) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
MINERAL OIL (UNII: T5L8T28FGP)  
SQUALANE (UNII: GW89575KF9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67510-0631-11 in 1 BOX12/12/2013
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/12/2013
Labeler - Kareway Product, Inc. (121840057)

Revised: 1/2023
Document Id: f344a0a6-5099-27b3-e053-2995a90a6c43
Set id: b249ea8c-5418-4189-a39b-ce0174fa60c6
Version: 5
Effective Time: 20230127
 
Kareway Product, Inc.