NDC 43846-0054 Joint Pain Stiffness Relief

Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (smilax Regelii)

NDC Product Code 43846-0054

NDC Code: 43846-0054

Proprietary Name: Joint Pain Stiffness Relief 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: Calendula Officinalis, Croton Tiglium, Natrum Muriaticum, Plantago Major, Rhus Tox, Sarsaparilla (smilax Regelii) 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 43846-0054-1

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Joint Pain Stiffness Relief with NDC 43846-0054 is a a human over the counter drug product labeled by Peaceful Mountain, Inc.. The generic name of Joint Pain Stiffness Relief is calendula officinalis, croton tiglium, natrum muriaticum, plantago major, rhus tox, sarsaparilla (smilax regelii). 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.

Joint Pain Stiffness Relief 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.

  • CALENDULA OFFICINALIS FLOWERING TOP 12 [hp_X]/mL
  • CROTON TIGLIUM SEED 30 [hp_X]/mL
  • SODIUM CHLORIDE 30 [hp_X]/mL
  • PLANTAGO MAJOR 30 [hp_X]/mL
  • TOXICODENDRON PUBESCENS LEAF 30 [hp_X]/mL
  • SMILAX REGELII ROOT 30 [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.

  • ALOE (UNII: V5VD430YW9)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)
  • COMFREY LEAF (UNII: DG4F8T839X)
  • CROTON LECHLERI RESIN (UNII: GGG6W25C63)
  • LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
  • SILVER (UNII: 3M4G523W1G)
  • MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SORBIC ACID (UNII: X045WJ989B)
  • PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)
  • PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM BICARBONATE (UNII: 8MDF5V39QO)
  • HYPERICUM ERECTUM FLOWERING TOP (UNII: IT0296HQDC)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • WHEY (UNII: 8617Z5FMF6)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)

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: 11-24-2015 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: 12-31-2019 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Joint Pain Stiffness Relief 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:

Calendula Officinalis 12X, Croton Tiglium 30X, Natrum Muriaticum 30X, Plantago Major 30X, Rhus Tox 30X, Sarsaparilla (Smilax Regelii) 30X.

Indications:

May temporarily relieve pain due to inflammation caused by but not limited to the following:  sprains, minor joint inflammation, trauma.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

May temporarily relieve pain due to inflammation caused by but not limited to the following: sprains, minor joint inflammation, trauma.****These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

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.Do not get into eyes.If symptoms persist, consult a doctor.Do not use if tamper evident 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:

Spray liberally on affected area as needed. Children under 12 years of age: consult a doctor.

Inactive Ingredients:

Aloe Barbadensis Leaf Juice, Arnica Montana Flower, Larrea Tridentata Leaf, Symphytum Officinale Leaf, Croton Lechleri Sap, Lavandula Angustifolia Buds, Ionic Colloidal Silver, Melissa Officinalis Leaf, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Phytolacca Americana Berries, Phytolacca Americana Root, Potassium Sorbate, Purified Water, Sodium Bicarbonate, Hypericum Perforatum Aerial Parts, Vitamin E Oil, Ascorbic Acid, Whey Protein Concentrate, Salix Alba Bark, Achillea Millefolium Flower

Questions:

Dist. by Peaceful Mountain, Inc.Woodbine, IA 51579 888-303-3388www.peacefulmountain.com

Package Label Display:

Peaceful mountainTHE HEIGHT OF HEALTHjoint pain & stiffness reliefhomeopathic spray1 fl. oz. (30 mL)

* Please review the disclaimer below.