Hot Flash Rescue

Manufacturer: Apotheca Company
Effective date: 2022-04-28
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-01 22:02:18

Label at a glance#

ProductHot Flash Rescue

Active ingredientCAPSICUM, PULSATILLA VULGARIS, SANGUINARIA CANADENSIS ROOT

Label structure9 sections

Contacts and useful links#

PhoneLabel contact888-303-3388

Websitewww.peacefulmountain.com

www.peacefulmountain.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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 SECTION

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 SECTION

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 SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

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

OTC - QUESTIONS SECTION

Dist. by Peaceful Mountain, Inc.

Woodbine, IA 51579

888-303-3388

www.peacefulmountain.com

patent pending

PACKAGE LABEL.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)

Hot Flash Rescue

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57520-0455-1	2022-04-28	C162847	48780-1	9d75b9cf-d92b-f424-e053-dadaa90a57ce	Hot Flash Rescue
57520-0455-1	2020-01-31	C162847	48780-1	9d75b9cf-d92b-f424-e053-dadaa90a57ce	Hot Flash Rescue

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CAPSICUM	ACTIVE INGREDIENT	00UK7646FG	1
PULSATILLA VULGARIS	ACTIVE INGREDIENT	I76KB35JEV	1
SANGUINARIA CANADENSIS ROOT	ACTIVE INGREDIENT	N9288CD508	1
CAPSICUM	ACTIVE MOIETY	00UK7646FG	1
PULSATILLA VULGARIS	ACTIVE MOIETY	I76KB35JEV	1
SANGUINARIA CANADENSIS ROOT	ACTIVE MOIETY	N9288CD508	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ALPHA-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	1
AVOCADO OIL	INACTIVE INGREDIENT	6VNO72PFC1	1
BLACK COHOSH	INACTIVE INGREDIENT	K73E24S6X9	1
CAPRYLYL GLYCOL	INACTIVE INGREDIENT	00YIU5438U	1
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S))	INACTIVE INGREDIENT	59TL3WG5CO	1
CHASTE TREE	INACTIVE INGREDIENT	433OSF3U8A	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	1
DIOSCOREA VILLOSA ROOT	INACTIVE INGREDIENT	IWY3IWX2G8	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
KUKUI NUT OIL	INACTIVE INGREDIENT	TP11QR7B8R	1
LAVANDULA ANGUSTIFOLIA FLOWER	INACTIVE INGREDIENT	19AH1RAF4M	1
MACADAMIA OIL	INACTIVE INGREDIENT	515610SU8C	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	1
OREGANO FLOWERING TOP	INACTIVE INGREDIENT	7K91ZBK8GJ	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	1
POLYETHYLENE GLYCOL 1500	INACTIVE INGREDIENT	1212Z7S33A	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	1
POLYETHYLENE GLYCOL 700	INACTIVE INGREDIENT	762678AC5R	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	1
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	1
ROSA CANINA FRUIT OIL	INACTIVE INGREDIENT	CR7307M3QZ	1
SAGE	INACTIVE INGREDIENT	065C5D077J	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	1
ST. JOHN'S WORT	INACTIVE INGREDIENT	UFH8805FKA	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 33 matching rows.

Hot Flash Rescue
Capsicum annuum, Pulsatilla, Sanguinaria canadensis,
CAPSICUM
PULSATILLA VULGARIS
SANGUINARIA CANADENSIS ROOT
ALOE VERA LEAF
AVOCADO OIL
BLACK COHOSH
CARBOMER INTERPOLYMER TYPE A (55000 CPS)
CHASTE TREE
WATER
EDETATE DISODIUM
KUKUI NUT OIL
LAVANDULA ANGUSTIFOLIA FLOWER
MACADAMIA OIL
OREGANO FLOWERING TOP
SAGE
OLIVE OIL
POLYETHYLENE GLYCOL 1500
POLYETHYLENE GLYCOL 400
DIMETHICONE
POLYETHYLENE GLYCOL 700
PHENOXYETHANOL
CAPRYLYL GLYCOL
SORBIC ACID
POLYSORBATE 20
POTASSIUM SORBATE
ROSA CANINA FRUIT OIL
SODIUM HYDROXIDE
ST. JOHN'S WORT
ASCORBIC ACID
ALPHA-TOCOPHEROL
DIOSCOREA VILLOSA ROOT

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57520-0455	57520-0455-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CAPSICUM	00UK7646FG	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
SANGUINARIA CANADENSIS ROOT	N9288CD508	ACTIB
ALOE VERA LEAF	ZY81Z83H0X	IACT
AVOCADO OIL	6VNO72PFC1	IACT
BLACK COHOSH	K73E24S6X9	IACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)	59TL3WG5CO	IACT
CHASTE TREE	433OSF3U8A	IACT
WATER	059QF0KO0R	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
KUKUI NUT OIL	TP11QR7B8R	IACT
LAVANDULA ANGUSTIFOLIA FLOWER	19AH1RAF4M	IACT
MACADAMIA OIL	515610SU8C	IACT
OREGANO FLOWERING TOP	7K91ZBK8GJ	IACT
SAGE	065C5D077J	IACT
OLIVE OIL	6UYK2W1W1E	IACT
POLYETHYLENE GLYCOL 1500	1212Z7S33A	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
DIMETHICONE	92RU3N3Y1O	IACT
POLYETHYLENE GLYCOL 700	762678AC5R	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
CAPRYLYL GLYCOL	00YIU5438U	IACT
SORBIC ACID	X045WJ989B	IACT
POLYSORBATE 20	7T1F30V5YH	IACT
POTASSIUM SORBATE	1VPU26JZZ4	IACT
ROSA CANINA FRUIT OIL	CR7307M3QZ	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
ST. JOHN'S WORT	UFH8805FKA	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
ALPHA-TOCOPHEROL	H4N855PNZ1	IACT
DIOSCOREA VILLOSA ROOT	IWY3IWX2G8	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 405 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBCUTANEOUS	1 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCUTANEOUS	31.45 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUSPENSION / ORAL		400 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
POTASSIUM SORBATE	POTASSIUM SORBATE	1VPU26JZZ4	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYETHYLENE GLYCOL 1500	POLYETHYLENE GLYCOL 1600	1212Z7S33A	SUPPOSITORY / RECTAL	0.3 mg/mg		Exact identifier — unii candidate 6 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	EMULSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SWAB / TOPICAL		5250 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAPERITONEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	SOLUTION / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 25 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	DISC / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SOLUTION / TOPICAL		11100 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	CAPSULE / ORAL		563 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAMUSCULAR	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SUSPENSION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	INJECTION / INTRAMUSCULAR		406 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOAP / TOPICAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASPINAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAMUSCULAR	1.62 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ORAL	400 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, LIQUID FILLED / ORAL	1.5 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION / INTRAVENOUS		30 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION / INTRAVENOUS		1440 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	CONCENTRATE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	TABLET, CHEWABLE / ORAL	0.1 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
OLIVE OIL	OLIVE OIL	6UYK2W1W1E	SOLUTION / TOPICAL	0.6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	GEL / TOPICAL		7 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, SOLUTION / SUBCUTANEOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAVITARY	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-AMNIOTIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	CAPSULE, DELAYED RELEASE / ORAL		26 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
POLYETHYLENE GLYCOL 400	POLYETHYLENE GLYCOL 400	B697894SGQ	SPRAY, METERED / NASAL		320 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
ALPHA-TOCOPHEROL	.ALPHA.-TOCOPHEROL	H4N855PNZ1	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 10 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	INJECTION / INTRACAVITARY	5 mg		Exact identifier — unii candidate 25 equally ranked IID candidates
POLYSORBATE 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 28 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
5419af8a-1318-4947-a69b-029b1e7c9345			2d872636-2e19-4f8b-ad61-160b892b4079	2022-04-28	Warnings	Exact identifier spl id: 5419af8a-1318-4947-a69b-029b1e7c9345 spl set id: 2d872636-2e19-4f8b-ad61-160b892b4079

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.