BALSAMIC LINIMENT- castor birch liniment 
Borisovskiy Zavod Medicinskikh Preparatov JSC

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.

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Drug facts

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. 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.

image of tube labelimage of packimage of group label

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)

Revised: 11/2015
Document Id: 256e7111-d06f-576e-e054-00144ff88e88
Set id: 2a001d2e-f076-4bfc-a61c-c8f8d8044fea
Version: 2
Effective Time: 20151126
 
Borisovskiy Zavod Medicinskikh Preparatov JSC