FAMILY WELLNESS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Family wellness by

Drug Labeling and Warnings

Family wellness 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)

Bacitracin 400 units

Neomycin 3.5 mg

Polymyxin B 5,000 units

PURPOSE

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

INDICATIONS & USAGE

Uses  first aid to help prevent infection in minor:

-uses     -scrapes   -burns

WARNINGS

Warnings

For external use only.

Do not use

• if you are allergic to any of the ingredients in this product
• in contact with the eyes or mucous membranes
• over large areas of the body

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• symptoms persist for mroe than 7 days, the condition persists or gets worse
• symptoms clear up and then occur again within a few days
• a 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 the affected area
• apply a small amount of this product to affected area 1 to 3 times daily
• May be covered with a sterile bandage.

Children under 2 years of age: ask a doctor before use.

STORAGE AND HANDLING

Other information  store at room temperature 68 - 77 F

(20-25 C).

QUESTIONS

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

INACTIVE INGREDIENT

Inactive ingredients  mineral oil, petrolatum

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69571-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	.41 g  in 100 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	.0035 g  in 100 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	.52 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: 69571-003-02	1 in 1 BOX	02/22/2017
1	NDC: 69571-003-01	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	02/22/2017

Labeler - FRONT PHARMACEUTICAL PLC (530897792)

Establishment
Name	Address	ID/FEI	Business Operations
FRONT PHARMACEUTICAL PLC		530897792	manufacture(69571-003)