Hot Flash Rescue
- Manufacturer
- Apotheca Company
- Effective date
- 2022-04-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:02:40
Label at a glance#
Contacts and useful links#
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 to hormone therapy.
DOSAGE & ADMINISTRATION SECTION
DIRECTIONS: Apply daily to neck, chest, abdomen, inner arms or inner thighs. Use as needed.
INACTIVE INGREDIENT SECTION
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.
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 the left ovarian region and burning palms and soles.
OTC - QUESTIONS SECTION
Dist. by Peaceful Mountain, Inc.
Woodbine, IA 51579
888-303-3388
no animal testing
patent pending
PACKAGE LABEL.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)
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 57520-0545-1 | 2022-04-25 | C162847 | 48780-1 | 9d75b9cf-ff59-f424-e053-dadaa90a57ce | Hot Flash Rescue |
| 57520-0545-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-ff59-f424-e053-dadaa90a57ce | Hot Flash Rescue |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| PAPRIKA | ACTIVE INGREDIENT | X72Z47861V | 2 | |
| PULSATILLA VULGARIS | ACTIVE INGREDIENT | I76KB35JEV | 2 | |
| SANGUINARIA CANADENSIS ROOT | ACTIVE INGREDIENT | N9288CD508 | 2 | |
| PAPRIKA | ACTIVE MOIETY | X72Z47861V | 2 | |
| PULSATILLA VULGARIS | ACTIVE MOIETY | I76KB35JEV | 2 | |
| SANGUINARIA CANADENSIS ROOT | ACTIVE MOIETY | N9288CD508 | 2 | |
| ALOE VERA LEAF | INACTIVE INGREDIENT | ZY81Z83H0X | 2 | |
| ALPHA-TOCOPHEROL | INACTIVE INGREDIENT | H4N855PNZ1 | 2 | |
| ASCORBIC ACID | INACTIVE INGREDIENT | PQ6CK8PD0R | 2 | |
| BLACK COHOSH | INACTIVE INGREDIENT | K73E24S6X9 | 2 | |
| CAPRYLYL GLYCOL | INACTIVE INGREDIENT | 00YIU5438U | 2 | |
| CHASTE TREE | INACTIVE INGREDIENT | 433OSF3U8A | 2 | |
| DIOSCOREA VILLOSA ROOT | INACTIVE INGREDIENT | IWY3IWX2G8 | 2 | |
| LAVANDULA ANGUSTIFOLIA FLOWER | INACTIVE INGREDIENT | 19AH1RAF4M | 2 | |
| OREGANO FLOWERING TOP | INACTIVE INGREDIENT | 7K91ZBK8GJ | 2 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 2 | |
| POTASSIUM SORBATE | INACTIVE INGREDIENT | 1VPU26JZZ4 | 2 | |
| SAGE | INACTIVE INGREDIENT | 065C5D077J | 2 | |
| SORBIC ACID | INACTIVE INGREDIENT | X045WJ989B | 2 | |
| ST. JOHN'S WORT | INACTIVE INGREDIENT | UFH8805FKA | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 2 |
Products#
Every source-derived product name is available through these pages.
- Hot Flash Rescue
- Capsicum annuum, Pulsatilla, Sanguinaria canadensis,
- PAPRIKA
- PULSATILLA VULGARIS
- SANGUINARIA CANADENSIS ROOT
- ALOE VERA LEAF
- BLACK COHOSH
- CHASTE TREE
- WATER
- LAVANDULA ANGUSTIFOLIA FLOWER
- OREGANO FLOWERING TOP
- SAGE
- PHENOXYETHANOL
- CAPRYLYL GLYCOL
- SORBIC ACID
- POTASSIUM SORBATE
- ST. JOHN'S WORT
- ASCORBIC ACID
- ALPHA-TOCOPHEROL
- DIOSCOREA VILLOSA ROOT
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57520-0545 | 57520-0545-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, CHEWABLE / ORAL | 0.1 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, DELAYED RELEASE / ORAL | 0.03 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CAPSULE, DELAYED RELEASE / ORAL | 12 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | CREAM / TOPICAL | 14 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET / ORAL | 6 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | OINTMENT / TOPICAL | NA | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | POWDER, FOR SUSPENSION / ORAL | 19 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | POWDER, FOR SOLUTION / ORAL | 560 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION, SOLUTION / INTRAVENOUS | 4 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CREAM / TOPICAL | 0.25 %w/w | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, COATED / ORAL | NA | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | SOLUTION / ORAL | 1.05 mg/1ml | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 0.11 %w/w | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | EMULSION / OPHTHALMIC | 0.47 %w/v | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SUSPENSION / ORAL | 40 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | LOTION / TOPICAL | 4 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET, FILM COATED / ORAL | 20 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION/ DROPS / OPHTHALMIC | 0.2 %w/v | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SUSPENSION / ORAL | 520 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION / INTRACAVITARY | 5 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SOLUTION/ DROPS / OPHTHALMIC | 0.47 %w/v | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CAPSULE / ORAL | 7 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, FILM COATED / ORAL | 5 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SYRUP / ORAL | 2 mg/1ml | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1440 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | GEL / TOPICAL | 2 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION, SOLUTION / INFILTRATION | 0.2 %w/v | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | TABLET, FILM COATED / ORAL | 246 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SPRAY, METERED / NASAL | 0.06 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | CREAM / TOPICAL | 57 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET / ORAL | 80 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CAPSULE / ORAL | NA | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, CHEWABLE / ORAL | NA | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | LOTION / TOPICAL | 1 %w/w | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SYRUP / ORAL | 80 mg | ||
| ALPHA-TOCOPHEROL | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | FILM, SOLUBLE / BUCCAL | 0.07 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION / OPHTHALMIC | 0.2 %w/v | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 1 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | TABLET, ORALLY DISINTEGRATING / ORAL | 2.35 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SYRUP / ORAL | 200 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | EMULSION / OPHTHALMIC | 1 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SUPPOSITORY / RECTAL | 3 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SOLUTION / ORAL | 600 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CAPSULE, EXTENDED RELEASE / ORAL | 17 mg | ||
| SORBIC ACID | SORBIC ACID | X045WJ989B | SOLUTION / ORAL | 80 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.1 %w/w | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 0.2 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SUSPENSION, EXTENDED RELEASE / ORAL | 6 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 2 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | CONCENTRATE / ORAL | 6 mg/1ml | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | GEL / TOPICAL | 7 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | CONCENTRATE / ORAL | 1 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | AEROSOL, FOAM / TOPICAL | 8 mg | ||
| POTASSIUM SORBATE | POTASSIUM SORBATE | 1VPU26JZZ4 | SUSPENSION / ORAL | 400 mg | ||
| ASCORBIC ACID | ASCORBIC ACID | PQ6CK8PD0R | SOLUTION / TOPICAL | 0.04 %w/w |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 8988c038-c45b-410c-988a-b1f761a4238e | fd00e730-e9ac-4aa2-8195-961a5513d04d | 2022-04-25 | Warnings | 8988c038-c45b-410c-988a-b1f761a4238e fd00e730-e9ac-4aa2-8195-961a5513d04d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
