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:

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)

INGREDIENTS AND APPEARANCE

HOT FLASH RESCUE 
capsicum annuum, pulsatilla, sanguinaria canadensis spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0007
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) (PULSATILLA VULGARIS - 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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0007-1	60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	03/19/2013	06/13/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/19/2013	06/13/2021

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0007)