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

Family Wellness Antiseptic and Pain Relief by

Drug Labeling and Warnings

Family Wellness Antiseptic and Pain Relief by is a Otc medication manufactured, distributed, or labeled by FRONT PHARMACEUTICAL PLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each gram)

Bacitricin zinc 500 units

Neomycin  3.5 mg

Polymyxin B  10,000 units

Pramoxine hydrochorlide 10 mg

PURPOSE

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever

INDICATIONS & USAGE

Uses

helps prevent infection in and reduces paid due to

minor cuts  scrapes  burns

WARNINGS

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

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.

DOSAGE & ADMINISTRATION

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

STORAGE AND HANDLING

Other information

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

INACTIVE INGREDIENT

Inactive ingredients mineral oil, white petrolatum

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	0.51 g  in 100 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	0.0035 g  in 100 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	1 g  in 100 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	0.01 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69571-007-01	1 in 1 CARTON	06/13/2017
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	06/13/2017

Labeler - FRONT PHARMACEUTICAL PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
FRONT PHARMACEUTICAL PLC		530897792	manufacture(69571-007)