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 Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS:  Capsicum annuum 3X, Pulsatilla 3X, Sanguinaria canadensis 3X.

PURPOSE

INDICATIONS:  For temporary relief of menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles.

WARNINGS

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 to hormone therapy.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:  Aloe vera concentrate, Black cohosh root, Chaste tree fruit, Lavender buds, Origanum vulgare, Salvia officinalis, Phenoxyethanol, Caprylyl glycol, Sorbic acid, Potassium sorbate, Purified water, Sage leaf, St. John's Wort aerial parts, Vitamin C, Vitamin E(soy) and Wild yam root.

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 & USAGE

INDICATIONS:  For temporary relief of menopausal disorders including flushes of heat, heavy menses with pain in the left ovarian region and burning palms and soles.

QUESTIONS

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

no animal testing

patent pending

PRINCIPAL DISPLAY PANEL

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: 57520-0545
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PAPRIKA (UNII: X72Z47861V) (PAPRIKA - UNII:X72Z47861V)	PAPRIKA	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)
WATER (UNII: 059QF0KO0R)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ)
SAGE (UNII: 065C5D077J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ST. JOHN'S WORT (UNII: UFH8805FKA)
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: 57520-0545-1	60 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/07/2011

Labeler - Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Business Operations
Apotheca Company		844330915	manufacture