Label: BALSAMIC LINIMENT- castor birch liniment
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Contains inactivated NDC Code(s)
NDC Code(s): 16638-042-42 - Packager: Borisovskiy Zavod Medicinskikh Preparatov JSC
- 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
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- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BALSAMIC LINIMENT
castor birch linimentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:16638-042 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CASTOR OIL (UNII: D5340Y2I9G) (CASTOR OIL - UNII:D5340Y2I9G) CASTOR OIL 35.6 g in 40 g BETULA PENDULA TAR OIL (UNII: 7JK2RXJ8G7) (BETULA PENDULA TAR OIL - UNII:7JK2RXJ8G7) BETULA PENDULA TAR OIL 1.2 g in 40 g Inactive Ingredients Ingredient Name Strength COLLOIDAL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2 g in 40 g BISMUTH TRIBROMOPHENATE (UNII: 5K96Y7WG8T) 1.2 g in 40 g Product Characteristics Color brown (From light brown to green-brown) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16638-042-42 40 g in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/22/2000 Labeler - Borisovskiy Zavod Medicinskikh Preparatov JSC (628149593) Establishment Name Address ID/FEI Business Operations Borisovskiy Zavod Medicinskikh Preparatov JSC 628149593 manufacture(16638-042)