HOT FLASH RESCUE- capsicum annuum, pulsatilla, sanguinaria candensis lotion

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 (Vulgaris) 3X, Sanguinaria Candensis 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 or 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 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. Begin with two metered pumps morning and evening: adjust dose for your personal needs and comfort.

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.

INACTIVE INGREDIENTS:

Aloe Vera Concentrate, Avocado Oil, Black Cohosh, Carbomer, Chaste Tree, Edetate Disodium, Kukui Nut Oil, Lavender, Macadamia Nut Oil, Natural Plant Extract, Olive Oil, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Capryly Glycol, Sorbic Acid, Polysorbate 20, Potassium Sorbate, Purified Water, Rose Hips Oil, Sage, Sodium Hydroxide, St. John's Wort, Vitamin C, Vitamin E Oil, Wild Yam

QUESTIONS:

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888.303.3388

www.peacefulmountain.com

PACKAGE DISPLAY LABEL:

peaceful mountain

THE HEIGHT OF HEALTH

​hot flash rescue

homeopathic lotion

paraban-free

formulated in boulder, co

​Net wt. 3.5 oz. (100 g)

INGREDIENTS AND APPEARANCE

HOT FLASH RESCUE 
capsicum annuum, pulsatilla, sanguinaria candensis lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43846-0033
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 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	3 [hp_X]  in 1 g
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508)	SANGUINARIA CANADENSIS ROOT	3 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVOCADO OIL (UNII: 6VNO72PFC1)
BLACK COHOSH (UNII: K73E24S6X9)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
CHASTE TREE (UNII: 433OSF3U8A)
EDETATE DISODIUM (UNII: 7FLD91C86K)
KUKUI NUT OIL (UNII: TP11QR7B8R)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MACADAMIA OIL (UNII: 515610SU8C)
OREGANO (UNII: 0E5AT8T16U)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SAGE (UNII: 065C5D077J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43846-0033-1	100 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/02/2014

Labeler - Peaceful Mountain, Inc. (078430707)

Registrant - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture(43846-0033) , api manufacture(43846-0033) , label(43846-0033) , pack(43846-0033)