OXALTEM- berberis vulgaris, oxalicum acidum, sanguinaria canadensis, chimaphila umbellata, calcarea fluorica, calcarea silicata, uricum acidum, calcarea phosphorica, parathormonum, pyridoxinum hydrochloricum liquid

Oxaltem by

Drug Labeling and Warnings

Oxaltem by is a Homeopathic medication manufactured, distributed, or labeled by Nucleic Products, LLC, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Berberis Vulgaris 6X, 9X, 12X, Oxalicum Acidum 6X, 9X, 12X, 30C, Sanguinaria Canadensis 9X, Chimaphila Umbellata 9X, 30C, Calcarea Fluorica 12X 30C, Calcarea Silicata 12X 30C, Uricum Acidum 12X, 30C, Calcarea Phosphorica 6C, 9C, 30C, Parathormonum 9C, Pyridoxinum Hydrochloricum 12C,

INDICATIONS:

Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage.

Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.

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:

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take one full dropper up to 2 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

Homeopathic medicine for the regulation of oxalate deposition and related dysfunctions of drainage.

Claims based on homeopathic theory, not accepted medical evidence. Not FDA evaluated.

INACTIVE INGREDIENTS

20% organic ethanol, purified water

QUESTIONS:

Distributed by: Nucleic Products, LLC

PO Box 7148 Grove, OK 74344

PACKAGE LABEL DISPLAY:

NDC: 75053-0009-1

Nu cleic

Oxaltem

Homeopathic Medicine

For Professional Use Only

4 fl oz. (118 ml)

INGREDIENTS AND APPEARANCE

OXALTEM 
berberis vulgaris, oxalicum acidum, sanguinaria canadensis, chimaphila umbellata, calcarea fluorica, calcarea silicata, uricum acidum, calcarea phosphorica, parathormonum, pyridoxinum hydrochloricum liquid

Product 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	07/26/2028

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/31/2022	07/26/2028

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)