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NDC 57520-0455-01 Hot Flash Rescue 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g Details
Hot Flash Rescue 3; 3; 3 [hp_X]/g; [hp_X]/g; [hp_X]/g
Hot Flash Rescue is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Apotheca Company. The primary component is CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT.
Product Information
| NDC | 57520-0455 |
|---|---|
| Product ID | 57520-0455_5419af8a-1318-4947-a69b-029b1e7c9345 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Hot Flash Rescue |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Capsicum annuum, Pulsatilla, Sanguinaria canadensis, |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOTION |
| Route | TOPICAL |
| Active Ingredient Strength | 3; 3; 3 |
| Active Ingredient Units | [hp_X]/g; [hp_X]/g; [hp_X]/g |
| Substance Name | CAPSICUM; PULSATILLA VULGARIS; SANGUINARIA CANADENSIS ROOT |
| Labeler Name | Apotheca Company |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Vegetable Proteins [CS] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED HOMEOPATHIC |
| Application Number | n/a |
| Listing Certified Through | n/a |
Package
Package Images
NDC 57520-0455-01 (57520045501)
| NDC Package Code | 57520-0455-1 |
|---|---|
| Billing NDC | 57520045501 |
| Package | 100 g in 1 BOTTLE, PUMP (57520-0455-1) |
| Marketing Start Date | 2011-06-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 2d872636-2e19-4f8b-ad61-160b892b4079 Details
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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.
SPL UNCLASSIFIED SECTION
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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.
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PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| HOT FLASH RESCUE
capsicum annuum, pulsatilla, sanguinaria canadensis, lotion |
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| Labeler - Apotheca Company (844330915) |
| Registrant - Apotheca Company (844330915) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Apotheca Company | 844330915 | manufacture(57520-0455) , api manufacture(57520-0455) , label(57520-0455) , pack(57520-0455) | |