HOT FLASH RESCUE- capsicum annuum, pulsatilla pratensis), sanguinaria canadensis spray 
Peaceful Mountain, Inc.

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.

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Drug Facts:

ACTIVE INGREDIENTS:

(in each spray): 0.33% of Capsicum Annuum 3X, Pulsatilla (Pratensis) 4X, Sanguinaria Canadensis 3X.

INDICATIONS:

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. **

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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. Use as needed.

INDICATIONS:

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. **

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

no animal testing

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

hot flash rescue

homeopathic spray

soothing mist

2 fl. oz. (59 ml)

Hot Flash Rescue

HOT FLASH RESCUE 
capsicum annuum, pulsatilla pratensis), sanguinaria canadensis spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0081
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 1 mL
PULSATILLA PRATENSIS WHOLE (UNII: 8E272251DI) (PULSATILLA PRATENSIS WHOLE - UNII:8E272251DI) PULSATILLA PRATENSIS WHOLE4 [hp_X]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0081-159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/18/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/18/2021
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0081) , api manufacture(43846-0081) , label(43846-0081) , pack(43846-0081)

Revised: 3/2021
 
Peaceful Mountain, Inc.