FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hci cream

FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF by

Drug Labeling and Warnings

FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by FAMILY DOLLAR. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each gram)                                                                                 Purpose

Neomycin 3.5mg .......................................................................................................First aid antibiotic

Polymyxin B sulfate 10,000 units ................................................................................First aid antibiotic

Pramoxine hydrochloride 10mg ...................................................................................Pain reliever

PURPOSE

Uses

first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

• cuts
• scrapes
• burns

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• if you are allergic to any of the ingredients
• in the eyes
• over large areas of the body

ASK DOCTOR

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns
  

STOP USE

Stop use and ask a doctor if

• you need to use longer than 1 week
• condition persists or gets worse
• symptoms persist for more than 1 week or clear up and occur again within a few days
• rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

INDICATIONS & USAGE

Directions Adults and children 2 years and older:

• clean affected area
• apply a small amount (equal to the surface area of the tip of a finger) on area 1 to 3 times daily
• may be covered with a sterile bandage

Children under 2 years: ask a doctor

STORAGE AND HANDLING

Other information

• Store between 20 oC and 25 oC (68 oF and 77 oF)
• Lot No. and Exp. Date: see box or see crimp of tube
  

INACTIVE INGREDIENT

Inactive ingredients

cetanol, methylparaben, mineral oil, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearic acid

DOSAGE & ADMINISTRATION

Distributed by:

Midwood Brands, LLC

10811 Monroe Rd.

Matthews, NC 28105

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
neomycin sulfate, polymyxin b sulfate, and pramoxine hci cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-033
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CETYL ALCOHOL (UNII: 936JST6JCN)
PARAFFIN (UNII: I9O0E3H2ZE)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 60 (UNII: CAL22UVI4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-033-28	1 in 1 CARTON	10/15/2012
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	10/15/2012

Labeler - FAMILY DOLLAR (024472631)