ROOSIN TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Roosin Triple Antibiotic by

Drug Labeling and Warnings

Roosin Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by ROOSIN MEDICAL CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Bacitracin Zinc 0.048%

Neomycin Sulfate 1%

Polymyxin B Sulfate 0.6%

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Use

First aid to help prevent infection in minor cuts scrapes burns

WARNINGS

For external use only

Do not use

• In the eyes
• Over large areas of the body
• If you are allergic to any of the ingredients
• Longer than 1 week unless directed by a doctor

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Directions

Clean affected area

Apply small amount 1  to 3 times daily

May be covered with a sterile bandage

Inactive ingredients

Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ROOSIN TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81552-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	0.048 g  in 100 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	1 g  in 100 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	0.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)
OCTADECANOL (MIXTURE OF ISOMERS) (UNII: C6BPY2QY39)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCEROL FORMAL (UNII: 3L7GR2604E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81552-005-01	0.5 g in 1 TUBE; Type 0: Not a Combination Product	04/24/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	04/24/2021

Labeler - ROOSIN MEDICAL CO., LTD (527587815)

Establishment
Name	Address	ID/FEI	Business Operations
ROOSIN MEDICAL CO., LTD		527587815	manufacture(81552-005)