Label: HOT FLASH RESCUE- capsicum annuum, pulsatilla pratensis, sanguinaria canadensis spray
- NDC Code(s): 43846-0081-1
- Packager: Peaceful Mountain, Inc.
- Category: HUMAN OTC 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 March 18, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS:
- INDICATIONS:
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WARNINGS:
For external use only. If pregnant, breast-feeding,taking birth control or on hormone replacement therapy, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
When using this product • Do not get into eyes.
Stop use and ask a doctor if Condition worsens - Symptoms last more than 7 days.
This product is not intended as an alternative hormone therapy.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
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INACTIVE INGREDIENTS:
Water, Wild Yam (Dioscorea Villosa) Root, Black Cohosh (Actaea Racemosa) Root, Chaste Tree (Vitex agnus-castus) Fruit, Lavender (Lavandula angustifolia) Buds, Sage (Salvia officinalis) Leaf, Ascorbic Acid, St John’s Wort (Hypericum Perforatum) Aerial Parts, Purified Water, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Aloe Barbadensis Leaf Juice, Tocopherols (soy), Natural Plant Extract, Potassium Sorbate, Ethanol, Citric Acid.
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
HOT FLASH RESCUE
capsicum annuum, pulsatilla pratensis), sanguinaria canadensis sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0081 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 3 [hp_X] in 1 mL PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE 4 [hp_X] in 1 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 3 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) ALOE VERA LEAF (UNII: ZY81Z83H0X) OREGANO (UNII: 0E5AT8T16U) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8) BLACK COHOSH (UNII: K73E24S6X9) CHASTE TREE FRUIT (UNII: 433OSF3U8A) LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M) SAGE (UNII: 065C5D077J) ASCORBIC ACID (UNII: PQ6CK8PD0R) HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) ALCOHOL (UNII: 3K9958V90M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0081-1 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 03/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/18/2021 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0081) , api manufacture(43846-0081) , label(43846-0081) , pack(43846-0081)
