Triple Antibiotic Plus Pain Relief Maximum Strength Ointment - Freds 

Triple Antibiotic Plus Pain Relief by

Drug Labeling and Warnings

Triple Antibiotic Plus Pain Relief by is a Otc medication manufactured, distributed, or labeled by Fred's Inc., Teva Pharmaceuticals USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 PLUS PAIN RELIEF  MAXIMUM STRENGTH
bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55315-823
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55315-823-34	1 in 1 CARTON	05/01/2009	12/31/2019
1		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	05/01/2009	12/31/2019

Labeler - Freds Inc (005866116)

Revised: 11/2019

Document Id: 234fbba9-678c-45d8-b9b7-82e7d7e0f366

34390-5

Set id: fbc3f6c2-07ca-4deb-a238-92c49e3984f2

Version: 6

Effective Time: 20191120