HARRIS TEETER TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment 
Harris Teeter

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 ingredients (in each gram)                                 Purpose

Bacitracin 500 units.......................................................First aid antibiotic

Neomycin 3.5 mg..........................................................First aid antibiotic

Polymyxin B 10,000 units...............................................First aid antibiotic

Pramoxine HCI 10 mg....................................................External analgesic

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

Warnings

For external use only.

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

ethanol, methylparaben, mineral oil, petrolatum, polyoxyl 40 stearate, propylparaben

Distributed by:

Harris Teeter, LLC

Matthews, NC 28105

Made in Korea

image description

HARRIS TEETER TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72036-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [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 B1000 [iU]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72036-401-141 in 1 CARTON04/18/2017
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/18/2017
Labeler - Harris Teeter (047279351)

Revised: 4/2017
Document Id: 617abc95-5372-4504-a80e-2fd51fa22e1d
Set id: 129f9544-19df-4afe-bf3c-be51582fa9df
Version: 1
Effective Time: 20170418
 
Harris Teeter