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:

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. **

**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. 

DIRECTIONS:

Apply daily to neck, chest, abdomen, inner arms or inner thighs.  Use as needed. 

INACTIVE INGREDIENTS:

Aloe Vera 10X Concentrate, Actaea Racemosa (root)[powder], Vitex Agnus-Castus (fruit)[powder], Lavender (buds), Natural plant extract (Origanox WS), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid (Optiphen-Plus), Potassium Sorbate, Purified Water, Salvia Officinalis (leaf), Hypericum Perforatum (aerial parts), Vitamin C (powder)[Ascorbic Acid], Vitamin E Oil (derived from Soy Bean), Dioscorea Villosa (root)[powder]

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.

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.

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA  51579

888-303-3388

www.peacefulmountain.com

PACKAGE LABEL DISPLAY:

peaceful mountain

THE HEIGHT OF HEALTH

hot flash rescue

homeopathic spray

soothing mist

formulated in boulder, co

2 fl. oz. (60 ml)

Hot Flash Recue Spray

HOT FLASH RESCUE 
capsicum annuum, pulsatilla, sanguinaria canadensis spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0007
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) (PULSATILLA VULGARIS - 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
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BLACK COHOSH (UNII: K73E24S6X9)  
CHASTE TREE (UNII: 433OSF3U8A)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
OREGANO (UNII: 0E5AT8T16U)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SORBIC ACID (UNII: X045WJ989B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
WATER (UNII: 059QF0KO0R)  
SAGE (UNII: 065C5D077J)  
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43846-0007-160 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/19/201306/13/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/19/201306/13/2021
Labeler - Peaceful Mountain, Inc. (078430707)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43846-0007)

Revised: 9/2018
 
Peaceful Mountain, Inc.