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

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 hormone therapy.

DOSAGE & ADMINISTRATION

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.

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:  Aloe vera concentrate, Avocado oil, Black cohosh root, Carbomer, Chaste tree fruit, Demineralized water, Edetate disodium, Kukui nut oil, Lavender buds, Macadamia nut oil, Origanum vulgare, Salvia officinalis, Olive oil, PEG-33, PEG-8, Dimethicone, PEG-14, Phenoxyethanol, Caprylyl glycol, Sorbic acid, Polysorbate 20, Potassium sorbate, Rose hips oil, Sodium hydroxide, St. John's Wort aerial parts, Vitamin C, Vitamin E (soy), Wild yam.

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 left ovarian region and burning palms and soles.

QUESTIONS

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

patent pending

PRINCIPAL DISPLAY PANEL

peaceful mountain

THE HEIGHT OF HEALTH

hot flash rescue

homeopathic lotion

paraben-free

organic and wild-crafted herbs

formulated in boulder, co

New wt. 3.5 oz (100 g)

INGREDIENTS AND APPEARANCE

HOT FLASH RESCUE 
capsicum annuum, pulsatilla, sanguinaria canadensis, lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57520-0455
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 (55000 MPA.S)) (UNII: 59TL3WG5CO)
CHASTE TREE (UNII: 433OSF3U8A)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
KUKUI NUT OIL (UNII: TP11QR7B8R)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
MACADAMIA OIL (UNII: 515610SU8C)
OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ)
SAGE (UNII: 065C5D077J)
OLIVE OIL (UNII: 6UYK2W1W1E)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBIC ACID (UNII: X045WJ989B)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
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: 57520-0455-1	100 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		06/21/2011

Labeler - Apotheca Company (844330915)

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