Label: ROOSIN BURN- lidocaine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 15, 2021

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  • Active Ingredient

    Banzalkonium Chloride 0.13%

    Lidocaine Chloride 0.5%

  • Purpose

    First Aid Antiseptic

    External Analgesic

    Antiseptic and antipyrotic

  • Use

    First aid to help prevent infection and for temporary relief of pain and itching associated with minor cuts scrapes burns

  • WARNINGS

    For external use only

    Do not use

    • In eyes
    • Over large areas of the body
    • For more than one week unless directed by a doctor
    • If you are allergic to any of the ingredients
    • On deep puncture wounds, animal bites, or serious burns

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

  • Directions

    Clean affected area

    Apply a small amount 1-3 times daily

    Children under 2: Consult doctor

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ROOSIN BURN 
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81552-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    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:81552-002-010.9 g in 1 TUBE; Type 0: Not a Combination Product04/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/20/2021
    Labeler - ROOSIN MEDICAL CO., LTD (527587815)
    Establishment
    NameAddressID/FEIBusiness Operations
    ROOSIN MEDICAL CO., LTD527587815manufacture(81552-002)
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