NDC 43846-0076 Back, Neck And Sciatic Rescue

Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Conium Maculatum

NDC Product Code 43846-0076

NDC CODE: 43846-0076

Proprietary Name: Back, Neck And Sciatic Rescue What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Phytolacca Decandra, Gnaphalium Polycephalum, Hypericum Perforatum, Colocynthis, Gelsemium Sempervirens, Guaiacum, Ledum Palustre, Conium Maculatum What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 43846 - Peaceful Mountain, Inc.

NDC 43846-0076-1

Package Description: 57 g in 1 TUBE

NDC Product Information

Back, Neck And Sciatic Rescue with NDC 43846-0076 is a a human over the counter drug product labeled by Peaceful Mountain, Inc.. The generic name of Back, Neck And Sciatic Rescue is phytolacca decandra, gnaphalium polycephalum, hypericum perforatum, colocynthis, gelsemium sempervirens, guaiacum, ledum palustre, conium maculatum. The product's dosage form is gel and is administered via topical form.

Labeler Name: Peaceful Mountain, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Back, Neck And Sciatic 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.

  • PHYTOLACCA AMERICANA ROOT 4 [hp_X]/g
  • PSEUDOGNAPHALIUM OBTUSIFOLIUM WHOLE 3 [hp_X]/g
  • HYPERICUM PERFORATUM WHOLE 3 [hp_X]/g
  • CITRULLUS COLOCYNTHIS FRUIT PULP 6 [hp_X]/g
  • GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]/g
  • GUAIACUM OFFICINALE RESIN 6 [hp_X]/g
  • RHODODENDRON TOMENTOSUM LEAFY TWIG 6 [hp_X]/g
  • CONIUM MACULATUM FLOWERING TOP 30 [hp_X]/g

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)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • OREGANO (UNII: 0E5AT8T16U)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • COMFREY LEAF (UNII: DG4F8T839X)
  • MACROPIPER METHYSTICUM ROOT (UNII: BOW48C81XP)
  • HYPERICUM PERFORATUM FLOWER (UNII: A6V4CUE7PV)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
  • LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)

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: 03-17-2021 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.

Back, Neck And Sciatic 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:

0.13% of Colocynthis 6X, Conium Maculatum 30X, Gelsemium Sempervirens 6X, Gnaphalium Polycephalum 3X, Guaiacum 6X, Hypericum Perforatum 3X, Ledum Palustre 6X, Phytolacca Decandra 4X.

Indications:

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve minor symptoms of back and neck discomfort and sharp pain along the sciatic nerve, lower back and down the back of the legs.****Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

For external use only.If pregnant or breast-feeding, 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 Conditions worsens · Symptoms last more than 7 days.Do not use if safety seal is broken or missing.

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 at least 3 times daily over the affected area.Children under 12 years of age: Consult a doctor.

Inactive Ingredients:

Water, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Sodium Hydroxide, acrylates/C10-30 Alkyl Acrylate Crosspolymer, Peg-33, Peg-8 Dimethicone, Peg-14, Aloe Vera, Tocopherols, Edetate Disodium (EDTA), Natural Plant extract, Potassium Sorbate, Arnica (Flower) Arnica Montana, Comfrey (Leaf) Symphytum Officinale, Kava (Root) Piper Methysticum, Poke (Root) Phytolacca Americana, St. John’s Wort (Leaf, Flower, Stem) Hypericum Perforatum, White Willow (Bark) Salix Alba, Yarrow (Flower) Achillea Millefolium, Lavender (buds) Lavandula Angustifolia, Ascorbic Acid.

Questions:

Dist. by Peaceful Mountain, Inc.Woodbine, IA 51579888-303-3388www.peacefulmountain.com

Package Label Display:

Back, neck andsciatic rescuepeaceful mountainTHE HEIGHT OF HEALTHhomeopathic gelparaben-freeformulated inboulder, coNet wt. 2 oz. (57 g)

* Please review the disclaimer below.