Label: HORMONE BALANCE (acetaldehyde, dopamine hydrochloride, dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, folliculinum, oophorinum- suis, cholesterinum, progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone liquid
- NDC Code(s): 62185-0050-1
- Packager: Dr. Donna Restivo DC
- 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 10, 2023
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ACTIVE INGREDIENTS:
Acetaldehyde 6X, 12X, 30X, 200X, Dopamine Hydrochloride 6X, 12X, 30X, 200X, DHEA (Dehydroepiandrosterone) 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, 7-Oxo-Dehydroepiandrosterone 3-Acetate 8X, 12X, 30X, 60X, 200X, 12C, 30C, 60C, 200C, Folliculinum 8X, 12X, 30X, 60X, 200X, 12C, 30C, 60C, 200C, Oophorinum (Suis) 8X, 12X, 30X, 60X, 200X, 12C, 30C, 60C, 200C, Cholesterinum 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 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:
Temporary relief of symptoms related to hormone imbalances or insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females) and lack of libido.**
**These statements are based upon traditional 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:
Temporary relief of symptoms related to hormone imbalances or insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females) and lack of libido.**
**These statements are based upon traditional 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 BALANCE
acetaldehyde, dopamine hydrochloride, dhea (dehydroepiandrosterone), 7-oxo-dehydroepiandrosterone-3b-acetate, folliculinum, oophorinum (suis), cholesterinum, progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62185-0050 Route of Administration ORAL DEA Schedule CIII Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETALDEHYDE (UNII: GO1N1ZPR3B) (ACETALDEHYDE - UNII:GO1N1ZPR3B) ACETALDEHYDE 6 [hp_X] in 1 mL DOPAMINE HYDROCHLORIDE (UNII: 7L3E358N9L) (DOPAMINE - UNII:VTD58H1Z2X) DOPAMINE HYDROCHLORIDE 6 [hp_X] in 1 mL 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE (UNII: 84RQ0XOM11) (7-OXODEHYDROEPIANDROSTERONE 3-ACETATE - UNII:84RQ0XOM11) 7-OXODEHYDROEPIANDROSTERONE 3-ACETATE 6 [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 CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL 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:62185-0050-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 09/03/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/03/2019 Labeler - Dr. Donna Restivo DC (790796940) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(62185-0050) , api manufacture(62185-0050) , label(62185-0050) , pack(62185-0050)
