BIOTIC-PLUS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine 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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TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

advanced Stops Pain and Prevents Infection for Cuts and Scrapes

BIOTIC-PLUS       0.5g

Active ingredients

(in each gram)

Bacitracin zinc (400 units Bacitracin)

Neomycin sulfate (3.5 mg neomycin)

Polymyxin B sulfate (5000 units)

Lidocaine .40 mg

Purpose

First Aid Antibiotic

First Aid Antibiotic

First Aid Antibiotic

Anesthetic

Uses

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

The Provision First Aid Line

Manufactured for Provision Medical Products Palm Desert, CA 92211

Warnings

For external use only.

Keep out of reach of children

If ingested, contact a Poison Control Center directly.

Do not use

  • in eyes or over large areas of the body
  • more than 1 week unless directed by a doctor
  • if allergic to ingredients.

Stop use, ask a doctor

  • in case of deep or puncture wounds, animal bites or serious burns
  • if conditions worsen or last more than 7 days
  • if rash or allergic reaction occurs

Directions

Inactive ingredients

white petrolatum

Principal Display Panel
BIOTIC-PLUS 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin400 [iU]  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 [iU]  in 1 g
lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987) lidocaine.40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-2400-10.5 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/24/2014
Labeler - Provision Medical (036936831)
Registrant - Safetec of America, Inc. (874965262)
Establishment
NameAddressID/FEIBusiness Operations
Safetec of America, Inc.874965262MANUFACTURE(69103-2400)

Revised: 7/2014
Document Id: 294cef14-6b97-4221-9f9e-13e9529194ff
Set id: 0d3af5c2-e24a-4070-a059-5f7ceacb6540
Version: 1
Effective Time: 20140724
 
Provision Medical