81552-004 Triple Antibiotic 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]

ROOSIN TRIPLE ANTIBIOTIC- hydrocortisone acetate ointment 
ROOSIN MEDICAL CO., LTD

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.

----------

81552-004 Triple Antibiotic Ointment

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

image description

ROOSIN TRIPLE ANTIBIOTIC 
hydrocortisone acetate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81552-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN0.048 g  in 100 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN1 g  in 100 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B0.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81552-004-010.5 g in 1 TUBE; Type 0: Not a Combination Product04/20/202104/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B04/20/202104/24/2021
Labeler - ROOSIN MEDICAL CO., LTD (527587815)
Establishment
NameAddressID/FEIBusiness Operations
ROOSIN MEDICAL CO., LTD527587815manufacture(81552-004)

Revised: 12/2021
Document Id: d3325ccb-0769-3f4a-e053-2a95a90aac2f
Set id: cc295782-a271-4dd6-8d78-9d50e9f4047f
Version: 3
Effective Time: 20211215