Triple Antibiotic Plus Pain Relief (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride) Ointment [Fred's, Inc.] -

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [FRED'S, INC.]
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NDC	55315-192-34
Set ID	a44db5d1-7a74-44aa-9aa7-6247e771aaf2
Category	HUMAN OTC DRUG LABEL
Packager	FRED'S, INC.
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each gram)	Purpose
Bacitracin zinc USP 500 units	First aid antibiotic
Neomycin sulfate USP 3.5 mg	First aid antibiotic
Polymyxin B sulfate USP 10,000 units	First aid antibiotic
Pramoxine HCl USP 10 mg	External analgesic

Uses
first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:
- cuts
- scrapes
- burns
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
- adults and children 2 years of age and older:
  - clean the 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 20° to 25°C (68° to 77°F)
- see carton or tube crimp for lot number and expiration date
Inactive ingredient

white petrolatum
Questions?

Call 1-866-923-4914
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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)

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55315-192
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [USP'U] in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin Sulfate	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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55315-192-34	1 in 1 CARTON	01/14/2019
1		14.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	03/31/2012

Labeler - FRED'S, INC. (005866116)

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Medic

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [FRED'S, INC.]

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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