Label: HOT FLASH RESCUE- not applicable lotion

  • 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 October 1, 2014

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  • ACTIVE INGREDIENTS:

    Capsicum Annuum 3X, Pulsatilla (Vulgaris) 3X, Sanguinaria Candensis 3X

  • INDICATIONS:

    For temporary relief of menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles.**

    **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • 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:

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS:

    Apply daily to neck, chest, abdomen, inner arms or inner thighs. Begin with two metered pumps morning and evening: adjust dose for your personal needs and comfort.

  • INDICATIONS:

    For temporary relief of menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles.**

    **These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • INACTIVE INGREDIENTS:

    Aloe Vera Concentrate, Avocado Oil, Black Cohosh Root, Carbomer (Ultrez 21), Chaste Tree Fruit, Edetate Disodium, Kukui Nut Oil, Lavender Buds, Macadamia Nut Oil, Natural Plant Extract, Olive Seed Oil, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Polysorbate 20, Potassium Sorbate, Purified Water, Rose Hips Seed Oil, Sage Leaf, Sodium Hydroxide, St. John's Wort Aerial Parts, Vitamin C, Vitamin E (Soy), Wild Yam Root

  • QUESTIONS:

    Dist. by Peaceful Mountain, Inc.

    Woodbine, IA 51579

    888.303.3388

    www.peacefulmountain.com

  • PACKAGE DISPLAY LABEL:

    peaceful mountain

    THE HEIGHT OF HEALTH

    hot flash rescue

    homeopathic lotion

    paraban-free

    organic and wild-crafted herbs

    formulated in boulder, co

    Net wt. 3.5 oz. (100 g)

    HOT FLASH RESCUE(LOTION) 3.5 OZ

  • INGREDIENTS AND APPEARANCE
    HOT FLASH RESCUE 
    not applicable lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0036
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 1 g
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS3 [hp_X]  in 1 g
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    BLACK COHOSH (UNII: K73E24S6X9)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CHASTE TREE (UNII: 433OSF3U8A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    OREGANO (UNII: 0E5AT8T16U)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    ROSA CANINA SEED (UNII: 4503R1M9UT)  
    SAGE (UNII: 065C5D077J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0036-1100 g in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/01/2014
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0036) , api manufacture(43846-0036) , label(43846-0036) , pack(43846-0036)
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