Label: BOLYM-EX DROPS- benzoic acid, formic acid, aristolochia clematitis root, asafetida, avena sativa flowering top, berberis vulgaris root bark, calcium phosphate, capsella bursa-pastoris, galium aparine, daphne mezereum bark, and piper methysticum root liquid
-
Contains inactivated NDC Code(s)
NDC Code(s): 54256-201-10 - Packager: BioResource Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated June 5, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Ingredients
- INACTIVE INGREDIENT
- Indications
- Dosage
- Warning
- STORAGE AND HANDLING
- Tamper Evident
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton
-
INGREDIENTS AND APPEARANCE
BOLYM-EX DROPS
benzoic acid, formic acid, aristolochia clematitis root, asafetida, avena sativa flowering top, berberis vulgaris root bark, calcium phosphate, capsella bursa-pastoris, galium aparine, daphne mezereum bark, and piper methysticum root liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54256-201 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoic Acid (UNII: 8SKN0B0MIM) (Benzoic Acid - UNII:8SKN0B0MIM) Benzoic Acid 5 [hp_X] in 50 mL Formic Acid (UNII: 0YIW783RG1) (Formic Acid - UNII:0YIW783RG1) Formic Acid 5 [hp_X] in 50 mL Aristolochia Clematitis Root (UNII: ZY0NX0W00D) (Aristolochia Clematitis Root - UNII:ZY0NX0W00D) Aristolochia Clematitis Root 24 [hp_X] in 50 mL Asafetida (UNII: W9FZA51AS1) (Asafetida - UNII:W9FZA51AS1) Asafetida 5 [hp_X] in 50 mL Avena Sativa Flowering Top (UNII: MA9CQJ3F7F) (Avena Sativa Flowering Top - UNII:MA9CQJ3F7F) Avena Sativa Flowering Top 4 [hp_X] in 50 mL Berberis Vulgaris Root Bark (UNII: 1TH8Q20J0U) (Berberis Vulgaris Root Bark - UNII:1TH8Q20J0U) Berberis Vulgaris Root Bark 5 [hp_X] in 50 mL Calcium Phosphate (UNII: 97Z1WI3NDX) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Phosphate 8 [hp_X] in 50 mL Capsella bursa-pastoris (UNII: W0X9457M59) (Capsella bursa-pastoris - UNII:W0X9457M59) Capsella bursa-pastoris 5 [hp_X] in 50 mL Galium aparine (UNII: Z4B6561488) (Galium aparine - UNII:Z4B6561488) Galium aparine 5 [hp_X] in 50 mL Daphne Mezereum Bark (UNII: X2N6E405GV) (Daphne Mezereum Bark - UNII:X2N6E405GV) Daphne Mezereum Bark 8 [hp_X] in 50 mL Piper Methysticum Root (UNII: BOW48C81XP) (Piper Methysticum Root - UNII:BOW48C81XP) Piper Methysticum Root 10 [hp_X] in 50 mL Inactive Ingredients Ingredient Name Strength Alcohol (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54256-201-10 1 in 1 CARTON 1 50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 06/01/2015 Labeler - BioResource Inc. (017532917) Establishment Name Address ID/FEI Business Operations PEKANA Naturheilmittel GmbH 320344542 MANUFACTURE(54256-201)