TRIPLE ANTIBIOTIC  - bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Morales Distributors 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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Triple Antibiotic

Active ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purposes

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

Ask a doctor before use if you have

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

store at 59 degrees to 77 degrees Fahrenheit

Inactive ingredients

Liquid paraffin, Cethanol, Squalane, Lanolin, Petrolatum, Tocopheryl acetate

Package label

NDC NO. 53210-1004-0

First Aid Prevent Infection

Cuts Scrapes Burns

Maximum Strength

Help Prevent Infection in Minor Cuts, Scrapes and Burns

Soothing Ointment

Original
TRIPLE ANTIBIOTIC
Polymyxin B Sulfate-Bacitracin Zinc-Neomycin Sulfate

Net 1 oz(28.3g)

Exclusively distributed by:
Morales Distributors, Inc
Mayaguez, P.R. 00682

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Original Neosporin (R)

Made in Korea

carton label 1

carton label 2

tube label


TRIPLE ANTIBIOTIC  
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53210-1004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 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 U  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
SQUALANE (UNII: GW89575KF9)  
LANOLIN (UNII: 7EV65EAW6H)  
PETROLATUM (UNII: 4T6H12BN9U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53210-1004-01 in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/26/2012
Labeler - Morales Distributors Inc. (127151731)

Revised: 10/2012
Document Id: 3173a08b-5f96-4c1e-8668-9c34360fb55f
Set id: c3f80241-58ec-4608-8807-482ba8c91eef
Version: 5
Effective Time: 20121001
 
Morales Distributors Inc.