Oxaltem: Homeopathic Product Information

OXALTEM- berberis vulgaris root bark, oxalic acid, sanguinaria canadensis whole, chimaphila umbellata, calcium fluoride, calcium silicate, uric acid, tribasic calcium phosphate, parathyroid hormone and pyridoxine hydrochloride liquid
Nucleic Products, LLC

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.

ACTIVE INGREDIENTS:

Berberis Vulgaris 6X, 9X, 12X, Oxalicum Acidum 6X, 9X, 12X, 30X, 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 soy or milk derivatives.

KEEP OUT OF REACH OF CHILDREN:

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 6856 Grove, OK 74344

PACKAGE LABEL DISPLAY:

NDC: 75053-0009-1

Nu cleic

Oxaltem

Homeopathic Medicine

For Professional Use Only

4 fl oz. (118 ml)

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BERBERIS VULGARIS ROOT BARK (BERBERIS VULGARIS ROOT BARK) BERBERIS VULGARIS ROOT BARK 6 [hp_X] in 1 mL OXALIC ACID (OXALIC ACID) OXALIC ACID 6 [hp_X] in 1 mL SANGUINARIA CANADENSIS WHOLE (SANGUINARIA CANADENSIS WHOLE) SANGUINARIA CANADENSIS WHOLE 9 [hp_X] in 1 mL CHIMAPHILA UMBELLATA (CHIMAPHILA UMBELLATA) CHIMAPHILA UMBELLATA 9 [hp_X] in 1 mL CALCIUM FLUORIDE (FLUORIDE ION) CALCIUM FLUORIDE 12 [hp_X] in 1 mL CALCIUM SILICATE (CALCIUM CATION) CALCIUM SILICATE 12 [hp_X] in 1 mL URIC ACID (URIC ACID) URIC ACID 12 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (CALCIUM CATION) CALCIUM CATION 6 [hp_C] in 1 mL PARATHYROID HORMONE (PARATHYROID HORMONE) PARATHYROID HORMONE 9 [hp_C] in 1 mL PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE 12 [hp_C] in 1 mL

Inactive Ingredients Ingredient Name Strength WATER ALCOHOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:75053-0009-1 118 mL in 1 BOTTLE, DROPPER None

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	Operations
Apotheca Company		844330915	manufacture (75053-0009), api manufacture (75053-0009), label (75053-0009), pack (75053-0009)

Revised: 01/2022 Nucleic Products, LLC