TRIPLE ANTIBIOTIC PLUS MAXIMUM STRENGTH- bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl ointment 
The Kroger Co.

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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Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, Pramoxine Hydrochloride

OTC - ACTIVE INGREDIENT

(in each gram)

Bacitracin zinc, USP 500 units

Neomycin Sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 10,000 units

Pramoxine hydrochloride, USP 10 mg

OTC - PURPOSE

First aid antibiotic/Pain reliever

USES

First aid to help prevent infection and for temporary relief of pain or discomfort due to

WARNINGS

For external use only

Allergy alert:

OTC - DO NOT USE

OTC - ASK A DOCTOR BEFORE USE IF YOU HAVE

OTC - WHEN USING THIS PRODUCT

OTC - STOP USE AND ASK A DOCTOR IF

OTC - KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center right away.

2  DOSAGE & ADMINISTRATION

Adults and children 2 years and older:

Children under 2 years: ask a doctor

OTHER INFORMATION

INACTIVE INGREDIENT

White petrolatum

OTC - QUESTIONS OR COMMENTS?

1-800-632-6900

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kroger®

QUALITY GUARANTEED

Compare to the active ingredients of NEOSPORIN® PLUS.

*See Back Panel.

maximum strength

TRIPLE ANTIBIOTIC OINTMENT

PLUS PAIN RELIEF

• Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine Hydrochloride

• First aid antibiotic plus topical pain reliever

NET WT 1 OZ (28 g)

08230611xx VC108014

268d8196-figure-01

268d8196-figure-02

CARTON LABEL

TRIPLE ANTIBIOTIC PLUS  MAXIMUM STRENGTH
bacitracin zinc,neomycin sulfate, polymyxin b sulfate, pramoxine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-823
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59450-823-561 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/01/2008
Labeler - The Kroger Co. (006999528)

Revised: 3/2013
Document Id: 268d8196-4b85-4382-8f93-cf126debb6a7
Set id: 56d941b5-3b4d-44c9-b800-714a7c18f4b9
Version: 1
Effective Time: 20130320
 
The Kroger Co.