TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment 
FRED'S, INC.

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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Triple Antibiotic
Plus Pain Relief

Drug Facts

Active ingredients (in each gram)Purpose
Bacitracin zinc USP 500 unitsFirst aid antibiotic
Neomycin sulfate USP 3.5 mgFirst aid antibiotic
Polymyxin B sulfate USP 10,000 unitsFirst aid antibiotic
Pramoxine HCl USP 10 mgExternal analgesic

Uses

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

Warnings

For external use only.

Do not use

  • if you are allergic to any of the ingredients
  • in the eyes
  • over large areas of the body

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • you need to use longer than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week, or clear up and occur again within a few days
  • rash or other allergic reaction develops

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

Directions

Other information

Inactive ingredient

white petrolatum

Questions?

Call 1-866-923-4914

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD,
MEMPHIS, TN 38118

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

TRIPLE ANTIBIOTIC
OINTMENT
+ PAIN RELIEF

MAXIMUM STRENGTH

Bacitracin Zinc USP • Neomycin Sulfate USP • Polymyxin B
Sulfate USP • Pramoxine Hydrochloride USP
FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT

Helps Prevent Infection in Minor Cuts, Scrapes,
and Burns Plus Maximum Strength Pain Relief.

NET WT 0.5 oz (14.2 g)

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
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:55315-192
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin Sulfate3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [USP'U]  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-192-341 in 1 CARTON01/14/2019
114.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B03/31/2012
Labeler - FRED'S, INC. (005866116)

Revised: 1/2019
Document Id: 33b18d7c-541e-4ef8-a6a8-fdb1c8a186d1
Set id: a44db5d1-7a74-44aa-9aa7-6247e771aaf2
Version: 1
Effective Time: 20190117
 
FRED'S, INC.