TRIPLE ANTIBIOTIC PLUS PAIN RELIEF MAXIMUM STRENGTH- bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment 
Freds 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 Maximum Strength Ointment - Freds 

Drug Facts

Active ingredients (in each gram)

Bacitracin zinc, USP 500 units
Neomycin 3.5 mg
Polymyxin B sulfate, USP 10,000 units
Pramoxine hydrochloride, USP 10 mg

Purposes

First aid antibiotic/Pain reliever

Uses

First aid to help prevent infection and for temporary relief of pain or discomfort due to

  • minor cuts
  • scrapes
  • burns

Warnings

For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients

Do not use

  • 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

When using this product

  • do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

  • condition perists or gets worse
  • symptoms last for more than 7 days or clear up and come back within a few days
  • a 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

Adults and children 2 years and older:

  • clean affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

Other information

  • Store at 59°-86°F (15°-30°C).
  • Before using any medication, read all label directions. Keep carton, it contains important information

Inactive ingredient

white petrolatum

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

PRINCIPAL DISPLAY PANEL

fred's Pharmacy

NDC 55315-823-34
HELPS PREVENT INFECTION IN
MINOR CUTS, SCRAPES & BURNS

MAXIMUM STRENGTH
TRIPLE ANTIBIOTIC + PAIN RELIEF
(BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE-PRAMOXINE HCL)

FIRST AID ANTIBIOTIC/PAIN RELIEVING OINTMENT

NET WT ½ OZ (14g)

Compare To The Active Ingredients In:
*Neosporin® + Pain Relief

Triple Antibiotic + Pain Relief
TRIPLE ANTIBIOTIC PLUS PAIN RELIEF  MAXIMUM STRENGTH
bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-823
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) NEOMYCIN3.5 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:55315-823-341 in 1 CARTON05/01/200912/31/2019
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 FINALpart333B05/01/200912/31/2019
Labeler - Freds Inc (005866116)

Revised: 11/2019
Document Id: 234fbba9-678c-45d8-b9b7-82e7d7e0f366
Set id: fbc3f6c2-07ca-4deb-a238-92c49e3984f2
Version: 6
Effective Time: 20191120
 
Freds Inc