DZA Brands, LLC Triple Antibiotic Ointment Drug Facts

Healthy Accents Triple Antibiotic by

Drug Labeling and Warnings

Healthy Accents Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by DZA Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTHY ACCENTS TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, polymyxin b 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.

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DZA Brands, LLC Triple Antibiotic Ointment Drug Facts

Active ingredients (in each gram)

Bacitracin zinc equivalent to 400 units bacitracin

Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 5,000 units as polymyxin B sulfate

Purpose

First aid antibiotic

Uses

first aid to help prevent infection 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
• 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. (1-800-222-1222)

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

Other information

• store at 20-25°C (68-77°F)

Inactive ingredients

cocoa butter, cottonseed oil, olive oil, sodium pyruvate, tocopheryl acetate, white petrolatum

Questions or comments?

1-866-322-2439

Principal Display Panel

#1 Doctor Recommended combination of active ingredients

Compare to Neosporin® active ingredients

triple antibiotic ointment

helps skin heal to look healthy

long lasting infection protection

NET WET 1 OZ (28g)

bacitracin zine – neomycin sulfate – polymyxin B sulfate

first aid antibiotic

HEALTHY ACCENTS TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin, polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55316-181
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U]  in 1 g
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	5000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
COCOA BUTTER (UNII: 512OYT1CRR)
COTTONSEED OIL (UNII: H3E878020N)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM PYRUVATE (UNII: POD38AIF08)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55316-181-64	1 in 1 CARTON	06/27/2014	08/31/2019
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	06/27/2014	08/31/2019

Labeler - DZA Brands LLC (090322194)

Revised: 11/2019

Document Id: d7ab5e5c-4509-4c5e-bbe9-083736f16cb4

34390-5

Set id: 3b37d2d3-48bb-46e3-a03f-550f59190621

Version: 2

Effective Time: 20191115

 

DZA Brands LLC