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Triple Antibiotic by Safetec of America, Inc.

Dosage form: ointment
Ingredients: bacitracin zinc 400[USP'U] in 1g, neomycin sulfate 3.5mg in 1g, polymyxin b sulfate 5000[USP'U] in 1g
Labeler: Safetec of America, Inc.
NDC Code: 61010-5600

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

First Aid

Drug Facts

Active Ingredient

Bacitracin Zinc 400 units

Neomycin sulfate (3.5 mg Neomycin)

Polymyxin B Sulfate 5000 units

Purpose

First Aid Antibiotics

Uses

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

Warnings

For external use only

Do not use
  • internally
  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients

Stop use and ask a doctor if
  • a rash or allergic reaction develops
  • condition worsens or persists

Keep out of reach of children.

If ingested, contact a Poison Control Center right away

Directions
  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage

Inactive ingredients

petrolatum

PRINCIPAL DISPLAY PANEL – pouch

Safetec

Triple Antibiotic
Ointment

0.9 g (1/32 oz.)

Safetec of America, Inc.
Buffalo, NY 14215
800-456-7077

PRINCIPAL DISPLAY PANEL – 144 count box

NDC 61010-5600-2

Safetec

First Aid

Triple Antibiotic Ointment

First Aid to Help Prevent
Infection in Minor Cuts,
Scrapes, and Burns

Reorder no. 53210
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:61010-5600
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bacitracin zinc (bacitracin zinc) bacitracin zinc400 [USP'U]  in 1 g
neomycin sulfate (neomycin) neomycin sulfate3.5 mg  in 1 g
polymyxin b sulfate (polymyxin b) polymyxin b sulfate5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:61010-5600-2144 POUCH (144 POUCH) in 1 BOX
1NDC:61010-5600-10.9 g in 1 POUCH
2NDC:61010-5600-325 POUCH (25 POUCH) in 1 BOX
2NDC:61010-5600-10.9 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/08/2011
Labeler - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIOperations
Safetec of America, Inc.874965262MANUFACTURE

Revised: 08/2011
 
Safetec of America, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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