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Triple Antibiotic by Morales Distributors Inc.

Dosage form: ointment
Ingredients: BACITRACIN ZINC 400U in 1g, NEOMYCIN SULFATE 3.5mg in 1g, POLYMYXIN B SULFATE 5000U in 1g
Labeler: Morales Distributors Inc.
NDC Code: 53210-1004

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.

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:

  • cuts
  • scrapes
  • burns

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
  • serious burns
  • deep or puncture wounds
  • animal bites

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 more than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week or clear up and occur again within a few days
  • 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
  • adults and children 2 years of age and older:
    • 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
  • children under 2 years of age: ask a doctor

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





TRIPLE ANTIBIOTIC  
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53210-1004
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN400 U  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B5000 U  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
SQUALANE 
LANOLIN 
PETROLATUM 
.ALPHA.-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:53210-1004-01 TUBE (TUBE) 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)

 
Morales Distributors Inc.

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Medically reviewed on Oct 1, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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