Winco Maximum Strength Triple Antibiotic (Bacitracin Zinc, Neomycin Sulfate, Poymyxin B Sulfate, And Pramoxine Hydrochrloride) Ointment [Winco Foods, Llc] -

WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]
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NDC	67091-272-28
Set ID	01b03c7e-6c4e-43aa-8480-aff1c2688f7f
Category	HUMAN OTC DRUG LABEL
Packager	WinCo Foods, LLC
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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ACTIVE INGREDIENT

Active ingredients 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..................................................................External analgesic
PURPOSE
Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:
- cuts
- scrapes
- burns
WARNINGS

Warnings

For external use only
DO NOT USE
Do not use
- if you are allergic to any of the ingredients
- in the eyes
- over large areas of the body
ASK DOCTOR
Ask a doctor before use if you have
- deep or puncture wounds
- animal bites
- serious burns
STOP USE
Stop use and ask a doctor if
- you need to use longer than 1 week
- the 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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control right away
INDICATIONS & USAGE
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
STORAGE AND HANDLING
Other information
- store between 20° to 25°C (68° to 77°F)
- Lot No. & Exp. Date: see box or see crimp of tube
Inactive Ingredients ;

petrolatum
DOSAGE & ADMINISTRATION

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704
Principle Display Panel -TUBE
WinCo Foods NDC 67091-272-28

Triple Antibiotic Plus Ointment
- Bacitracin Zinc
- Neomycin Sulfate
- Polymyxin B Sulfate
- Pramoxine HCL
NET WT 1 OZ (28g)
Principle Display Panel -CARTON
WinCo Foods NDC 67091-272-28

Triple Antibiotic Plus Ointment
- Bacitracin Zinc
- Neomycin Sulfate
- Polymyxin B Sulfate
- Pramoxine HCL
NET WT 1 OZ (28g)

INGREDIENTS AND APPEARANCE

WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, poymyxin b sulfate, and pramoxine hydrochrloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67091-272
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	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:67091-272-28	1 in 1 CARTON	02/10/2015
1		28 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	02/10/2015

Labeler - WinCo Foods, LLC (056098817)

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Medic

WINCO MAXIMUM STRENGTH TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE) OINTMENT [WINCO FOODS, LLC]

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