Label: OSTEODIN-Z- rhus toxicondendron, hypericum perforatum, ruta graveolens, bellis perrnnis, methyl salicylate, menthol ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69825-003-01, 69825-003-02 - 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 February 8, 2016
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- DOSAGE & ADMINISTRATION
- WARNINGS
- INACTIVE INGREDIENT
- PURPOSE
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
OSTEODIN-Z
rhus toxicondendron, hypericum perforatum, ruta graveolens, bellis perrnnis, methyl salicylate, menthol ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69825-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 0.36 g in 30 g RUTA GRAVEOLENS WHOLE (UNII: 181JI0338P) (RUTA GRAVEOLENS WHOLE - UNII:181JI0338P) RUTA GRAVEOLENS WHOLE 0.36 g in 30 g BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 0.36 g in 30 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 2.25 g in 30 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.18 g in 30 g Inactive Ingredients Ingredient Name Strength METHYL SALICYLATE (UNII: LAV5U5022Y) 1.44 g in 30 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69825-003-02 1 in 1 BOX 02/08/2016 1 NDC:69825-003-01 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/08/2016 Labeler - Adven Biotech Private Limited (858029164) Establishment Name Address ID/FEI Business Operations Adven Biotech Private Limited 858029164 relabel(69825-003) , manufacture(69825-003) , repack(69825-003)
