Drug Facts:

Drug Facts:
SPL v4
SPL
SPL Set ID ab35fadf-5213-486b-b313-e676420efff7
Route
ORAL
Published
Effective Date 2023-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Berberis Vulgaris Root Bark (6 [hp_X]) Oxalic Acid (9 [hp_X]) Sanguinaria Canadensis Whole (12 [hp_X]) Chimaphila Umbellata Whole (6 [hp_C]) Fluoride Ion (9 [hp_C]) Calcium Cation (12 [hp_C]) Uric Acid Parathyroid Hormone Pyridoxine
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Completed Since 2022-01-31 Until 2028-07-26

Description

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,


Medication Information

Description

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,

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.

Questions:

Distributed by: Nucleic Products, LLC

PO Box 7148 Grove, OK 74344

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.

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,

Inactive Ingredients

20% organic ethanol, purified water

Package Label Display:

NDC: 75053-0009-1

Nu cleic

Oxaltem

Homeopathic Medicine

For Professional Use Only

4 fl oz. (118 ml)

Keep Out of Reach of Children:

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


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Distributed by: Nucleic Products, LLC

PO Box 7148 Grove, OK 74344

Directions: (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: (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.

Active Ingredients: (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,

Inactive Ingredients (INACTIVE INGREDIENTS)

20% organic ethanol, purified water

Package Label Display: (PACKAGE LABEL DISPLAY:)

NDC: 75053-0009-1

Nu cleic

Oxaltem

Homeopathic Medicine

For Professional Use Only

4 fl oz. (118 ml)

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.


Advanced Ingredient Data


Raw Label Data

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