ANTIBIOTIC AND PAIN RELIEF MAXIMUM STRENGTH- bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl ointment 
Kinray, Inc.

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

ACTIVE INGREDIENTS

(in each gram)

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

PURPOSES

First aid antibiotic/Pain reliever

USES

Helps prevent infection in and temporarily relieves pain due to

WARNINGS

For external use only

Allergy alert:

DO NOT USE

ASK A DOCTOR BEFORE USE IF YOU HAVE

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

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 and older:

Children under 2 years: ask a doctor

INACTIVE INGREDIENT

White petrolatum

QUESTIONS?

1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday-Friday.

Store at 59º - 86ºF (15º - 30ºC).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*Compare to the active ingredients in Neosporin®+ Pain Relief

Preferred plus ++++ Pharmacy

ANTIBIOTIC + PAIN RELIEF

MAXIMUM STRENGTH OINTMENT

BACITRACIN ZINC – NEOMYCIN SULFATE - POLYMYXIN B SULFATE - PRAMOXINE HCl

FIRST AID ANTIBIOTIC /PAIN RELIEVING OINTMENT

NET WT 1 OZ (28 G)

INFECTION PROTECTION

FOR BURNS, CUTS & SCRAPES

Maximum Strength Pain Relief Ointment

08230209A1 VC109276

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CARTON LABEL

ANTIBIOTIC AND PAIN RELIEF  MAXIMUM STRENGTH
bacitracin zinc neomycin sulfate polymyxin b sulfate pramoxine hcl ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63777-082
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [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 B SULFATE10000 [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:63777-082-311 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/01/2010
Labeler - Kinray, Inc. (012574513)

Revised: 6/2012
Document Id: e7bfff6a-ae4d-4a6e-9f10-b53edfd198d8
Set id: f7cc938e-d724-4716-a64d-4d8f93dca09b
Version: 1
Effective Time: 20120611
 
Kinray, Inc.