Label: HORMONE HARMONY (salsolinol (hydrochloride), dhea (dehydroepiandrosterone), 7-oxo- dehydroepiandrosterone-3b-acetate (7-keto), cholesterinum, folliculinum, oophorinum- suis, progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone liquid
- NDC Code(s): 62902-0012-1
- Packager: Intentional Nourishment
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: CIII
- 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 January 24, 2022
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ACTIVE INGREDIENTS:
Salsolinol (Hydrochloride) 6X, 12X, 30X, 200X, DHEA (Dehydroepiandrosterone) 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, 7-Oxo-Dehydroepiandrosterone-3B-acetate (7-Keto) 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Cholesterinum 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Folliculinum 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Oophorinum (Suis) 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Progesterone 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Testosterone 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Cortisone Aceticum 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Aldosterone 12C, 30C, 60C, 200C, Androsterone 12C, 30C, 60C, 200C, Follicle Stimulating Hormone 12C, 30C, 60C, 200C.
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HOMEOPATHIC INDICATIONS:
For temporary relief of symptoms related to menstrual and cyclic related conditions including emotional swings, headache, irritability, cravings and fluid retention in both menopause and andropause.**
**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
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HOMEOPATHIC INDICATIONS:
For temporary relief of symptoms related to menstrual and cyclic related conditions including emotional swings, headache, irritability, cravings and fluid retention in both menopause and andropause.**
**These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
HORMONE HARMONY
salsolinol (hydrochloride), dhea (dehydroepiandrosterone), 7-oxo- dehydroepiandrosterone-3b-acetate (7-keto), cholesterinum, folliculinum, oophorinum (suis), progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62902-0012 Route of Administration ORAL DEA Schedule CIII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALSOLINOL HYDROCHLORIDE, (+/-)- (UNII: 1C0F27WEAL) (SALSOLINOL HYDROCHLORIDE, (+/-)- - UNII:1C0F27WEAL) SALSOLINOL HYDROCHLORIDE, (+/-)- 6 [hp_X] in 1 mL PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B) PRASTERONE 6 [hp_X] in 1 mL 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE (UNII: 84RQ0XOM11) (7-OXODEHYDROEPIANDROSTERONE 3-ACETATE - UNII:84RQ0XOM11) 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE 8 [hp_X] in 1 mL CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL 8 [hp_X] in 1 mL ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE 8 [hp_X] in 1 mL SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY 8 [hp_X] in 1 mL PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE 8 [hp_X] in 1 mL TESTOSTERONE (UNII: 3XMK78S47O) (TESTOSTERONE - UNII:3XMK78S47O) TESTOSTERONE 8 [hp_X] in 1 mL CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE 12 [hp_X] in 1 mL ALDOSTERONE (UNII: 4964P6T9RB) (ALDOSTERONE - UNII:4964P6T9RB) ALDOSTERONE 12 [hp_C] in 1 mL ANDROSTERONE (UNII: C24W7J5D5R) (ANDROSTERONE - UNII:C24W7J5D5R) ANDROSTERONE 12 [hp_C] in 1 mL FOLLITROPIN (UNII: 076WHW89TW) (FOLLITROPIN - UNII:076WHW89TW) FOLLITROPIN 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:62902-0012-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 10/22/2018 12/12/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/22/2018 12/12/2023 Labeler - Intentional Nourishment (036906156) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(62902-0012) , api manufacture(62902-0012) , label(62902-0012) , pack(62902-0012)