HEALTHY ACCENTS TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride ointment
DZA Brands LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Active ingredient (in each gram)

Bacitracin 500 units

Neomycin 3.5 mg

Polymyxin-B 10,000 units

Pramoxine HCl 10 mg

Purpose

First aid antibiotic

External analgesic

Uses

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

cuts
scrapes
burns

Warnings

For external use only

Do not use

if you are allergic to any of the 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

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.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age or older
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
children under 2 years of age: ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

white petrolatum

Questions or comments?

1-866-322-2439

Principal Display Panel

Compare To Neosporin® Active Ingredients

maximum strength

triple antibiotic ointment

bacitracin zinc - neomycin sulfate - polymyxin-B sulfate - pramoxine HCl

first aid antibiotic pain relieving ointment

Triple Antibiotic Ointment Carton Image 1

Triple Antibiotic Ointment Carton Image 2

HEALTHY ACCENTS TRIPLE ANTIBIOTIC
bacitracin, neomycin, polymyxin b, pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55316-679
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (BACITRACIN)	BACITRACIN	500 [USP'U] in 1 g
NEOMYCIN SULFATE (NEOMYCIN)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B)	POLYMYXIN B	10000 [USP'U] in 1 g
PRAMOXINE HYDROCHLORIDE (PRAMOXINE)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM

Product Characteristics
Color	WHITE (Translucent)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:55316-679-64	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	12/08/2010

Labeler - DZA Brands LLC (090322194)

Revised: 12/2010

Document Id: 41976749-c339-4850-b0fa-1987584723bf

Set id: 41976749-c339-4850-b0fa-1987584723bf

Version: 1

Effective Time: 20101208

DZA Brands LLC