Publix Antibiotic Plus Pain Relief (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride) Ointment [Publix Super Markets Inc] -

PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PUBLIX SUPER MARKETS INC]
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NDC	41415-050-75
Set ID	0680644c-a466-4038-aed5-1173a14508e8
Category	HUMAN OTC DRUG LABEL
Packager	Publix Super Markets Inc
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (each gram contains)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine hydrochloride 10 mg	Topical 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
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week
Ask a doctor before use
- on deep or puncture wounds, animal bites, or serious burns
Stop use and ask a doctor if
- condition gets worse
- condition persists for more than 7 days
- condition clears up and occurs again 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 of age and older:
- clean the affected area and dry thoroughly
- 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: consult a doctor
Other information
- To open: unscrew cap, pull tab to remove foil seal
- store at room temperature
- see carton or tube crimp for lot number and expiration date
Inactive ingredient

white petrolatum
SPL UNCLASSIFIED SECTION

DISTRIBUTED BY PUBLIX
SUPER MARKETS, INC.
3300 PUBLIX CORPORATE
PARKWAY
LAKELAND, FL 33811
PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Publix
antibioticointment+
PAIN
RELIEF
POLYMYXIN B SULFATE • BACITRACIN ZINC • NEOMYCIN SULFATE
• PRAMOXINE HYDROCHLORIDE

FIRST AID ANTIBIOTIC OINTMENT PLUS PAIN RELIEVER

NET WT 1 OZ (28.4g)

INGREDIENTS AND APPEARANCE

PUBLIX 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:41415-050
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [iU] 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 [iU] 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
Packaging
1	NDC:41415-050-75	1 in 1 CARTON
1		28.4 g in 1 TUBE

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

Labeler - Publix Super Markets Inc (006922009)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Name	Address	ID/FEI	Business Operations
Establishment
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(41415-050)

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Medic

PUBLIX ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [PUBLIX SUPER MARKETS INC]

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