DERMFREE TRIPLE ANTIBIOTIC- triple antibiotic ointment

DERMFREE Triple Antibiotic by

Drug Labeling and Warnings

DERMFREE Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by Jiangxi Hemei Pharmaceutical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Bacitracin zinc 500 units
Neomycin sulfate equivalent to 3.5 mg of neomycin base

Polymyxin B 10,000 units as polymyxin B

Purpose

First aid antibiotic

Use

first aid to help prevent infection in minor: .cuts .ecrapes .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

When Using

Ask a doctor before use if you have

.deep or puncture wounds .animal bites .serious burns

Stop Use

Stop Use

.you need to use longer than l week

.condition persists or gets worse

.rash or other allergic reaction develops

Ask Doctor

.deep or puncture wounds .animal bites .serious burns

Keep Oot 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 equalto the surface area of the tip of a finger)on the area l 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMFREE TRIPLE ANTIBIOTIC 
triple antibiotic ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84010-039
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN ZINC	500 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g
POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WHITE PETROLATUM (UNII: B6E5W8RQJ4)
COTTONSEED OIL (UNII: H3E878020N)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCOA BUTTER (UNII: 512OYT1CRR)
OLIVE OIL (UNII: 6UYK2W1W1E)
SODIUM PYRUVATE (UNII: POD38AIF08)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84010-039-01	20 g in 1 TUBE; Type 0: Not a Combination Product	10/25/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	10/25/2024

Labeler - Jiangxi Hemei Pharmaceutical Co., Ltd (724892056)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangxi Hemei Pharmaceutical Co., Ltd		724892056	manufacture(84010-039)