DR TEALS TRIPLE ANTIBIOTIC- bactracin, neomycin, polymyxin b ointment

Array by

Drug Labeling and Warnings

Array by is a Otc medication manufactured, distributed, or labeled by Advanced Beauty Systems, Inc., Faria Limited dba Sheffield Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram) Purpose

Bacitracin 400 units First aid antibiotic

Neomycin 3.5mg First aid antibiotic

Polymyxin B 5,000 units First aid antibiotic

Uses first aid to help prevent infection in minor -cuts -scrapes -burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

-you need to use longer than 1 week

-condition persists or gets worse

-rash or other allergic reaction develop

Warnings For external use only

Do not use -if you are allergic to any ingredients -in the eyes -over large areas of the body

Ask a doctor before use if you have -deep or puncture wounds -animal bites -serious burns

Directions

-clean the affected area

-apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily

-may be covered with a sterile bandage

Inactive Ingredient: White Petrolatum

PRINCIPAL DISPLAY PANEL

Dr Teals

Therapeutic Solutions

First aid relief

Triple Antibiotic Ointment

Bacitracin Zinc

Neomycin Sulfate

Polymyxin B Sulfate

Prevents infection in minor cuts, scrapes, and burns

Net Wt 28 g 1oz

INGREDIENTS AND APPEARANCE

DR TEALS  TRIPLE ANTIBIOTIC
bactracin, neomycin, polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51345-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 U  in 28 g
NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 28 g
POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 U  in 28 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51345-106-01	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	08/06/2012

Labeler - Advanced Beauty Systems, Inc. (129986613)

Registrant - Advanced Beauty Systems, Inc. (129986613)

Establishment
Name	Address	ID/FEI	Business Operations
Faria Limited dba Sheffield Pharmaceuticals		151177797	manufacture(51345-106)