HYPOTHALTEM- eupatorium perfoliatum, berberis vulgaris, mentha pulegium, moschus, benzinum, sepia, baryta carbonica, glandula suprarenalis suis, hypophysis suis, hypothalamus suis, thyroidinum (suis), pyridoxinum hydrochloricum, gelsemium sempervirens, natrum carbonicum, nux vomica, staphysagria 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.

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DRUG FACTS:

ACTIVE INGREDIENTS:

Eupatorium Perfoliatum 6X, Berberis Vulgaris 9X, Mentha Pulegium 9X, 6C, Moschus 9X, 6C, Benzinum 9X, 30C, Sepia 9X, 30C, Baryta Carbonica 12X, 30C, Glandula Suprarenalis Suis 7C, Hypophysis Suis 7C, Hypothalamus Suis 7C, Thyroidinum 7C, Pyridoxinum Hydrochloricum 12C, Gelsemium Sempervirens 30C, Natrum Carbonicum 30C, Nux Vomica 30C, Staphysagria 30C.

INDICATIONS:

Homeopathic medicine for the regulation of hypothalamic function.

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:

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 hypothalamic function.

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: 75053-0010-1

Nu cleic

Hypothaltem

Homeopathic Medicine

For Professional Use Only

4 fl oz. (118 ml)

Hypothaltem

HYPOTHALTEM
eupatorium perfoliatum, berberis vulgaris, mentha pulegium, moschus, benzinum, sepia, baryta carbonica, glandula suprarenalis suis, hypophysis suis, hypothalamus suis, thyroidinum (suis), pyridoxinum hydrochloricum, gelsemium sempervirens, natrum carbonicum, nux vomica, staphysagria liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:75053-0010
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	6 [hp_X] in 1 mL
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	9 [hp_X] in 1 mL
MENTHA PULEGIUM WHOLE (UNII: 5Q6Y7K4846) (MENTHA PULEGIUM WHOLE - UNII:5Q6Y7K4846)	MENTHA PULEGIUM WHOLE	9 [hp_X] in 1 mL
MOSCHUS MOSCHIFERUS MUSK SAC RESIN (UNII: 8KFK4W7KP7) (MOSCHUS MOSCHIFERUS MUSK SAC RESIN - UNII:8KFK4W7KP7)	MOSCHUS MOSCHIFERUS MUSK SAC RESIN	9 [hp_X] in 1 mL
BENZENE (UNII: J64922108F) (BENZENE - UNII:J64922108F)	BENZENE	9 [hp_X] in 1 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	9 [hp_X] in 1 mL
BARIUM CARBONATE (UNII: 6P669D8HQ8) (BARIUM CATION - UNII:V645272HLN)	BARIUM CARBONATE	12 [hp_X] in 1 mL
SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV)	SUS SCROFA ADRENAL GLAND	7 [hp_C] in 1 mL
SUS SCROFA PITUITARY GLAND (UNII: L0PFEMQ1DT) (SUS SCROFA PITUITARY GLAND - UNII:L0PFEMQ1DT)	SUS SCROFA PITUITARY GLAND	7 [hp_C] in 1 mL
SUS SCROFA HYPOTHALAMUS (UNII: N6R0856Z79) (SUS SCROFA HYPOTHALAMUS - UNII:N6R0856Z79)	SUS SCROFA HYPOTHALAMUS	7 [hp_C] in 1 mL
THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P)	THYROID, UNSPECIFIED	7 [hp_C] in 1 mL
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	12 [hp_C] in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	30 [hp_C] in 1 mL
SODIUM CARBONATE (UNII: 45P3261C7T) (CARBONATE ION - UNII:7UJQ5OPE7D)	SODIUM CARBONATE	30 [hp_C] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_C] in 1 mL
DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV)	DELPHINIUM STAPHISAGRIA SEED	30 [hp_C] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:75053-0010-1	118 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/11/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/11/2021

Labeler - Nucleic Products, LLC (117470417)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(75053-0010) , api manufacture(75053-0010) , label(75053-0010) , pack(75053-0010)