NDC 43846-0081 Hot Flash Rescue

Capsicum Annuum, Pulsatilla Pratensis), Sanguinaria Canadensis

NDC Product Code 43846-0081

NDC 43846-0081-1

Package Description: 59 mL in 1 BOTTLE, SPRAY

NDC Product Information

Hot Flash Rescue with NDC 43846-0081 is a a human over the counter drug product labeled by Peaceful Mountain, Inc.. The generic name of Hot Flash Rescue is capsicum annuum, pulsatilla pratensis), sanguinaria canadensis. The product's dosage form is spray and is administered via topical form.

Labeler Name: Peaceful Mountain, Inc.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Hot Flash Rescue Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAPSICUM 3 [hp_X]/mL
  • PULSATILLA PRATENSIS WHOLE 4 [hp_X]/mL
  • SANGUINARIA CANADENSIS ROOT 3 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SORBIC ACID (UNII: X045WJ989B)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • OREGANO (UNII: 0E5AT8T16U)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
  • BLACK COHOSH (UNII: K73E24S6X9)
  • CHASTE TREE FRUIT (UNII: 433OSF3U8A)
  • LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
  • SAGE (UNII: 065C5D077J)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)
  • ALCOHOL (UNII: 3K9958V90M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Peaceful Mountain, Inc.
Labeler Code: 43846
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-18-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hot Flash Rescue Product Label Images

Hot Flash Rescue Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

(in each spray): 0.33% of Capsicum Annuum 3X, Pulsatilla (Pratensis) 4X, Sanguinaria Canadensis 3X.

Indications:

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. ****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve menopausal disorders including flushes of heat, heavy menses with pain in left ovarian region and burning palms and soles. ****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

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.

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.

Directions:

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

Inactive Ingredients:

Water, Wild Yam (Dioscorea Villosa) Root, Black Cohosh (Actaea Racemosa) Root, Chaste Tree (Vitex agnus-castus) Fruit, Lavender (Lavandula angustifolia) Buds, Sage (Salvia officinalis) Leaf, Ascorbic Acid, St John’s Wort (Hypericum Perforatum) Aerial Parts, Purified Water, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Aloe Barbadensis Leaf Juice, Tocopherols (soy), Natural Plant Extract, Potassium Sorbate, Ethanol, Citric Acid.

Questions:

Dist. by Peaceful Mountain, Inc.Woodbine, IA 51579888-303-3388www.peacefulmountain.comno animal testing

Package Label Display:

Peaceful mountainTHE HEIGHT OF HEALTHhot flash rescuehomeopathic spraysoothing mist2 fl. oz. (59 ml)

* Please review the disclaimer below.