TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment 
Provision Medical

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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Active ingredient

(in each gram)

Bacitracin zinc (400 units bacitracin)

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Use

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

Warnings

For external use only

Do not use

  • 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

Inactive ingredients

petrolatum

Principal Display Panel - 0.5g Packet Label

TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

ointment

Helps Prevent Infection in Cuts and Scrapes

TRIPLE ANTIBIOTIC

0.5g

The Provision First Aid LineTM

Principal Display Panel - 0.5g Packet Label
TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-5005
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
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-5005-10.5 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/29/2014
Labeler - Provision Medical (036936831)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-5005)

Revised: 8/2014
Document Id: 2a1ca9f4-e0b9-4540-bb99-091ad0404e17
Set id: 1cfd7b7b-a661-4889-b2a6-ab3ecf18f1f8
Version: 1
Effective Time: 20140829
 
Provision Medical