HOT FLASH RESCUE- capsicum annuum, pulsatilla, sanguinaria canadensis spray

Hot Flash Rescue by

Drug Labeling and Warnings

Hot Flash Rescue by is a Homeopathic medication manufactured, distributed, or labeled by Peaceful Mountain, Inc., Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

HOT FLASH RESCUE 
capsicum annuum, pulsatilla, sanguinaria canadensis spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0074
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 VULGARIS (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	PULSATILLA VULGARIS	3 [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 (UNII: 433OSF3U8A)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
SAGE (UNII: 065C5D077J)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0074-1	59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/31/2018

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0074) , api manufacture(43846-0074) , label(43846-0074) , pack(43846-0074)