Label: ESMENOPA- not applicable spray
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Contains inactivated NDC Code(s)
NDC Code(s): 64249-0003-1 - Packager: VitaMed, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- 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 August 18, 2014
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
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INDICATIONS:
May temporarily relieve these symptoms associated with hormonal imbalance, which may accompany menopause: mood swings, hot flashes, irritability, vaginal dryness, lack of sexual vitality. **
**These statements are based upon traditional homeopathic practice. They have not been reviewed by the U.S. Food and Drug Administration.
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS:
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INDICATIONS:
May temporarily relieve these symptoms associated with hormonal imbalance, which may accompany menopause: mood swings, hot flashes, irritability, vaginal dryness, lack of sexual vitality. **
**These statements are based upon traditional homeopathic practice. They have not been reviewed by the U.S. Food and Drug Administration.
- INACTIVE INGREDIENTS:
- QUESTIONS:
- PACKAGE LABEL DISPALY
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INGREDIENTS AND APPEARANCE
ESMENOPA
not applicable sprayProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64249-0003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHASTE TREE (UNII: 433OSF3U8A) (CHASTE TREE - UNII:433OSF3U8A) CHASTE TREE 3 [hp_X] in 1 mL ANGELICA SINENSIS ROOT (UNII: B66F4574UG) (ANGELICA SINENSIS ROOT - UNII:B66F4574UG) ANGELICA SINENSIS ROOT 3 [hp_X] in 1 mL APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA 6 [hp_X] in 1 mL AMERICAN GINSENG (UNII: 8W75VCV53Q) (AMERICAN GINSENG - UNII:8W75VCV53Q) AMERICAN GINSENG 3 [hp_X] in 1 mL ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_X] in 1 mL BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 3 [hp_X] in 1 mL GALIUM APARINE (UNII: Z4B6561488) (GALIUM APARINE - UNII:Z4B6561488) GALIUM APARINE 3 [hp_X] in 1 mL GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA 3 [hp_X] in 1 mL SUS SCROFA OVARY (UNII: S7YTV04R8O) (SUS SCROFA OVARY - UNII:S7YTV04R8O) SUS SCROFA OVARY 30 [hp_C] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 30 [hp_C] in 1 mL THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG 6 [hp_X] in 1 mL VISCUM ALBUM FRUITING TOP (UNII: BK9092J5MP) (VISCUM ALBUM FRUITING TOP - UNII:BK9092J5MP) VISCUM ALBUM FRUITING TOP 3 [hp_X] 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:64249-0003-1 30 mL in 1 BOTTLE, SPRAY Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/18/2014 Labeler - VitaMed, LLC (079364194) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(64249-0003) , api manufacture(64249-0003) , label(64249-0003) , pack(64249-0003)
