Label: BALSAMIC LINIMENT- castor birch liniment

  • 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 November 26, 2015

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  • Active Ingredients

    Castor Oil - 35.6 g, Birch Oil - 1.2 g

  • Purpose

    Analgesic - dermatologicals

  • Uses

    Effective in the treatment of wounds, ulcers, bedsores and shallow inflammatory processes (trombophlebitis, erysipelas).

  •  Warnings

    For external use only.

    Avoid contact with eyes. If contact occurs, rinse eyes throughly with water.

    Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center Immediately.

  • Directions

    Apply to affected areas one to two times daily or as directed by physician.

  • Other information

    Keep at temperature below 62 oF (15  oC).

  • Inactive ingredients

    Colloidal silicon dioxide, Xeroform.

  • PRINCIPAL DISPLAY PANEL

    image of tube labelimage of packimage of group label

  • INGREDIENTS AND APPEARANCE
    BALSAMIC LINIMENT 
    castor birch liniment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16638-042
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CASTOR OIL (UNII: D5340Y2I9G) (CASTOR OIL - UNII:D5340Y2I9G) CASTOR OIL35.6 g  in 40 g
    BETULA PENDULA TAR OIL (UNII: 7JK2RXJ8G7) (BETULA PENDULA TAR OIL - UNII:7JK2RXJ8G7) BETULA PENDULA TAR OIL1.2 g  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2 g  in 40 g
    BISMUTH TRIBROMOPHENATE (UNII: 5K96Y7WG8T) 1.2 g  in 40 g
    Product Characteristics
    Colorbrown (From light brown to green-brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16638-042-4240 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33412/22/2000
    Labeler - Borisovskiy Zavod Medicinskikh Preparatov JSC (628149593)
    Establishment
    NameAddressID/FEIBusiness Operations
    Borisovskiy Zavod Medicinskikh Preparatov JSC628149593manufacture(16638-042)
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