Label: OXALTEM- berberis vulgaris, oxalicum acidum, sanguinaria canadensis, chimaphila umbellata, calcarea fluorica, calcarea silicata, uricum acidum, calcarea phosphorica, parathormonum, pyridoxinum hydrochloricum liquid
- NDC Code(s): 75053-0009-1
- Packager: Nucleic Products, LLC
- 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 July 14, 2023
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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WARNINGS:
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if seal is broken or missing.
This Product does not contain sugar, starch, salt, preservatives, artificial flavors or additives, and no wheat, gluten, soy or milk derivatives.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
- INACTIVE INGREDIENTS
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
OXALTEM
berberis vulgaris, oxalicum acidum, sanguinaria canadensis, chimaphila umbellata, calcarea fluorica, calcarea silicata, uricum acidum, calcarea phosphorica, parathormonum, pyridoxinum hydrochloricum liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75053-0009 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 6 [hp_X] in 1 mL OXALIC ACID (UNII: 9E7R5L6H31) (OXALIC ACID - UNII:9E7R5L6H31) OXALIC ACID 6 [hp_X] in 1 mL SANGUINARIA CANADENSIS WHOLE (UNII: B3XJA0OV6T) (SANGUINARIA CANADENSIS WHOLE - UNII:B3XJA0OV6T) SANGUINARIA CANADENSIS WHOLE 9 [hp_X] in 1 mL CHIMAPHILA UMBELLATA WHOLE (UNII: WCK21A9W9J) (CHIMAPHILA UMBELLATA WHOLE - UNII:WCK21A9W9J) CHIMAPHILA UMBELLATA WHOLE 9 [hp_X] in 1 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 12 [hp_X] in 1 mL CALCIUM SILICATE (UNII: S4255P4G5M) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SILICATE 12 [hp_X] in 1 mL URIC ACID (UNII: 268B43MJ25) (URIC ACID - UNII:268B43MJ25) URIC ACID 12 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 6 [hp_C] in 1 mL PARATHYROID HORMONE (UNII: N19A0T0E5J) (PARATHYROID HORMONE - UNII:N19A0T0E5J) PARATHYROID HORMONE 9 [hp_C] in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 12 [hp_C] in 1 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:75053-0009-1 118 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 01/31/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/31/2022 Labeler - Nucleic Products, LLC (117470417) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(75053-0009) , api manufacture(75053-0009) , label(75053-0009) , pack(75053-0009)
