PREMIER VALUE TRIPLE ANTIBIOTIC PLUS- bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment

PREMIER VALUE TRIPLE ANTIBIOTIC PLUS by

Drug Labeling and Warnings

PREMIER VALUE TRIPLE ANTIBIOTIC PLUS by is a Otc medication manufactured, distributed, or labeled by TAI GUK PHARM. CO., LTD., UNITED EXCHANGE CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each gram)                                                                           Purpose

Bacitracin zinc 500 units ......................................................................................First aid antibiotic

Neomycin 3.5 mg ................................................................................................First aid antibiotic

Polymyxin B sulfate 10,000 units ..........................................................................First aid antibiotic

Pramoxine hydrochloride 10 mg ............................................................................Pain reliever

PURPOSE

Uses

helps prevent infection and temporarily relieves pain due to minor cuts, scrapes, and burns.

WARNINGS

Warnings

For external use only

Allergy alert: do not use if allergies to any of the ingredients

DO NOT USE

Do not use

• in or near 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
  

WHEN USING

When using this product

do not use longer than 1 week

STOP USE

Stop use and ask a doctor if

• condition lasts or gets worse
• symptoms last for more than 7 days or clear up and come back within a few days
• rash or other allergic reaction occurs
  

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions    Adults and children 2 years and older:

• clean affected area
• apply a small amount (equal to the surface area of the tip of a finger) on area 1 to 3 times daily
• may be covered with a sterile bandage
• Children under 2 years: ask a doctor
  

INACTIVE INGREDIENT

Inactive ingredients

white petrolatum

DOSAGE & ADMINISTRATION

Distributed By:

Chain Drug Consortium, LLC.

3301 N.W. Corporate Blvd. Suite 101

Boca Raton, FL 33431

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

PREMIER VALUE TRIPLE ANTIBIOTIC PLUS 
bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68169-0129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [USP'U]  in 1 g
NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B SULFATE	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: 68169-0129-5	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	11/04/2010

Labeler - TAI GUK PHARM. CO., LTD. (631101656)

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
TAI GUK PHARM. CO., LTD.		631101656	manufacture