FAMILY WELLNESS ANTISEPTIC AND PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment 
FRONT PHARMACEUTICAL PLC

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Family Wellness Antiseptic and Pain Relief

Active ingredients (in each gram)

Bacitricin zinc 500 units

Neomycin  3.5 mg

Polymyxin B  10,000 units

Pramoxine hydrochorlide 10 mg

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

Uses

helps prevent infection in and reduces paid due to

•minor cuts  •scrapes  •burns

Warnings  For external use only

Allergy alert

•do not use if allergic to any of the ingredients

Do not use

•in or near eyes

•on large areas of the body

Ask a doctor before use if you have

•deep or puncture wounds

•animal bites  •serious burns

When using this product

•do not use longer than 1 week

Stop use and ask a doctor if

•condtions last or gets worse

•symptoms last for more than 7 days or clear up and

come back within a few days

•if rash or other allergic reaction occurs

. If swallowed, get medical Keep out of reach of children

help or contact a Poison Control Center right away.

Directions

•adults and children 2 years of age and older:

   •clean affected area

   •apply a small amount (equal to surface area of tip of 

   finger) on area 1 to 3 times dailt

   •may be covered by a sterile bandage

•children under 2 years of age:

   •ask a doctor

Other information

•store at room temperature 68° - 77° (20° - 25° C)

mineral oil, white petrolatum Inactive ingredients

  1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

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FAMILY WELLNESS ANTISEPTIC AND PAIN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hydrochloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69571-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN0.51 g  in 100 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE0.0035 g  in 100 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B1 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE0.01 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69571-007-011 in 1 CARTON06/13/2017
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00406/13/2017
Labeler - FRONT PHARMACEUTICAL PLC (530897792)
Establishment
NameAddressID/FEIBusiness Operations
FRONT PHARMACEUTICAL PLC530897792manufacture(69571-007)

Revised: 10/2023
Document Id: 08a19db8-4da9-6529-e063-6394a90a1b4d
Set id: cb7fdcde-2bd8-4834-ba4e-4d6fd1512599
Version: 4
Effective Time: 20231026
 
FRONT PHARMACEUTICAL PLC