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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated April 24, 2021

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  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    ROOSIN TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81552-005
    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:81552-005-010.5 g in 1 TUBE; Type 0: Not a Combination Product04/24/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/24/2021
    Labeler - ROOSIN MEDICAL CO., LTD (527587815)
    Establishment
    NameAddressID/FEIBusiness Operations
    ROOSIN MEDICAL CO., LTD527587815manufacture(81552-005)
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