BALSAMIC LINIMENT (CASTOR BIRCH) LINIMENT [BORISOVSKIY ZAVOD MEDICINSKIKH PREPARATOV JSC]

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BALSAMIC LINIMENT (CASTOR BIRCH) LINIMENT [BORISOVSKIY ZAVOD MEDICINSKIKH PREPARATOV JSC]
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NDC 16638-042-42
Set ID 2a001d2e-f076-4bfc-a61c-c8f8d8044fea
Category HUMAN OTC DRUG LABEL
Packager Borisovskiy Zavod Medicinskikh Preparatov JSC
Generic Name
Product Class
Product Number
Application Number PART334
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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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