HOT FLASH RESCUE- capsicum annuum, pulsatilla, 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 3X, Sanguinaria Canadensis 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. **

**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:

For temporary relief of 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:

Extract Blend (Purified 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 (and) Caprylyl Glycol (and) Sorbic Acid, Aloe Barbadensis Leaf Juice, Tocopherols (soy), Natural Plant Extract and Potassium Sorbate.

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

formulated in boulder, co

2 fl. oz. (59 ml)

Hot Flash Rescue

HOT FLASH RESCUE 
capsicum annuum, pulsatilla, sanguinaria canadensis spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0074
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM3 [hp_X]  in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) PULSATILLA VULGARIS3 [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 (UNII: 433OSF3U8A)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
SAGE (UNII: 065C5D077J)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0074-159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/201811/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/31/201811/12/2023
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0074) , api manufacture(43846-0074) , label(43846-0074) , pack(43846-0074)

Revised: 12/2021
 
Peaceful Mountain, Inc.