Label: OSTEODIN-Z- dulcamara, amica montana, ruta gravelolens, rhus toxicodendron, actaea racemosa, formica rufa liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 69825-001-01, 69825-001-02 - Packager: Adven Biotech Private Limited
- 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 May 23, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Adults: Please open both A and B bottles and mix the contents
in the bigger empty bottle provided. Shake and then use 20
drops twice daily diluted with one tablespoon (approx. 15 ml)
of water. The dose should be reduced as the symptoms
improve. Children under 18 years : Please consult your
healthcare provider.
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- DESCRIPTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OSTEODIN-Z
dulcamara, amica montana, ruta gravelolens, rhus toxicodendron, actaea racemosa, formica rufa liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69825-001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 3 [hp_C] in 30 mL RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 4 [hp_C] in 30 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 4 [hp_C] in 30 mL FORMICA RUFA (UNII: 55H0W83JO5) (FORMICA RUFA - UNII:55H0W83JO5) FORMICA RUFA 4 [hp_C] in 30 mL ACTAEA RACEMOSA WHOLE (UNII: SS9QP678NG) (ACTAEA RACEMOSA WHOLE - UNII:SS9QP678NG) ACTAEA RACEMOSA WHOLE 4 [hp_C] in 30 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 3 [hp_C] in 30 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69825-001-02 2 in 1 CARTON 1 NDC:69825-001-01 30 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/18/2015 Labeler - Adven Biotech Private Limited (858029164) Establishment Name Address ID/FEI Business Operations Adven Biotech Private Limited 858029164 manufacture(69825-001) , relabel(69825-001) , repack(69825-001)
