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Triple Antibiotic by Safetec of America, Inc.

Medically reviewed on September 17, 2018

Dosage form: ointment
Ingredients: bacitracin zinc 400[iU] in 1g, neomycin sulfate 3.5mg in 1g, polymyxin b sulfate 5000[iU] in 1g
Labeler: Safetec of America, Inc.
NDC Code: 61010-5603

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 Ointment™

Drug Facts

Active Ingredient (in each gram)

Bacitracin Zinc (400 units Bacitracin)

Neomycin Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base)

Polymyxin-B Sulfate 5000 units

Purposes

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Uses

First aid to help prevent infection in minor cuts, scrapes and burns

Warnings

For external use only

Do not use:
  • in the eyes
  • internally
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask a doctor before use:
  • in case of deep or puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if:
  • the condition persists or gets worse
  • a rash or other allergic reaction develops

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a poison control center immediately.

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

Other Information
  • Store at room temperature (do not freeze)
  • Do Not Use any Opened or Torn Packets

Inactive Ingredient

Petrolatum

Questions or Comments? 1-800-456-7077

Manufactured by
SAFETEC OF AMERICA, Inc.
Buffalo, NY 14215 • 800-456-7077
www.safetec.com

PRINCIPAL DISPLAY PANEL – 0.5g Pouch Label

Safetec

Triple Antibiotic Ointment™

0.5 g (1/57 oz.)

Safetec of America, Inc.

Buffalo, NY 14215

800-456-7077

PRINCIPAL DISPLAY PANEL – Box Label

NDC 61010-5603-4

Safetec

First Aid

Triple Antibiotic Ointment™

First Aid to Help Prevent

Infection In Minor Cuts,

Scrapes, and Burns

Reorder no. 53214

To reorder:

Call: 1-800-456-7077

Fax: 716-895-2969

Online: www.safetec.com

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-5603
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bacitracin zinc (bacitracin zinc) bacitracin zinc400 [iU]  in 1 g
neomycin sulfate (neomycin) neomycin sulfate3.5 mg  in 1 g
polymyxin b sulfate (polymyxin b) polymyxin b sulfate5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:61010-5603-4144 POUCH (144 POUCH) in 1 BOX
1NDC:61010-5603-20.5 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/30/2007
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE

 
Safetec of America, Inc.

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Further information

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

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