NDC 43689-0031 Leg And Back Pain Relief

Atropa Belladonna, Capsicum, Citrullus Colocynthis Fruit Pulp, Magnesium Phosphate, Dibasic, Toxicodendron Radicans Leaf, Hypericum Perforatum

NDC Product Code 43689-0031

NDC CODE: 43689-0031

Proprietary Name: Leg And Back Pain 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: Atropa Belladonna, Capsicum, Citrullus Colocynthis Fruit Pulp, Magnesium Phosphate, Dibasic, Toxicodendron Radicans Leaf, Hypericum Perforatum 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

NDC 43689-0031-1

Package Description: 113 g in 1 JAR

NDC 43689-0031-2

Package Description: 1 JAR in 1 BOX > 113 g in 1 JAR

NDC Product Information

Leg And Back Pain Relief with NDC 43689-0031 is a a human over the counter drug product labeled by The Magni Group Inc. The generic name of Leg And Back Pain Relief is atropa belladonna, capsicum, citrullus colocynthis fruit pulp, magnesium phosphate, dibasic, toxicodendron radicans leaf, hypericum perforatum. The product's dosage form is cream and is administered via topical form.

Labeler Name: The Magni Group Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Leg And Back Pain 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.

  • ATROPA BELLADONNA 3 [hp_X]/113g
  • CAPSICUM 3 [hp_X]/113g
  • CITRULLUS COLOCYNTHIS FRUIT PULP 3 [hp_X]/113g
  • MAGNESIUM PHOSPHATE, DIBASIC 3 [hp_X]/113g
  • TOXICODENDRON RADICANS LEAF 3 [hp_X]/113g
  • HYPERICUM PERFORATUM 3 [hp_X]/113g

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 VERA LEAF (UNII: ZY81Z83H0X)
  • BENZOCAINE (UNII: U3RSY48JW5)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • ROSA CANINA FLOWER (UNII: 81MCR2UQ6Q)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • FOLIC ACID (UNII: 935E97BOY8)
  • LAURETH-7 (UNII: Z95S6G8201)
  • MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • SAGE (UNII: 065C5D077J)
  • SAGE OIL (UNII: U27K0H1H2O)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)
  • WATER (UNII: 059QF0KO0R)
  • ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)

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: The Magni Group Inc
Labeler Code: 43689
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: 06-08-2017 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: 12-31-2021 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.

Leg And Back Pain Relief Product Label Images

Leg And Back Pain 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

Banewort (Belladona) 3X HPUSCayenne Pepper (


Capsicum annuum) 3X HPUS


Colocynth (


Citrullus colocynthis) 3X HPUS


Gnaphalium polycephalum 3X HPUS


Magnesium Hydrogen Phosphate 3X HPUSPoison Ivy (


Rhus tox) 3X HPUS


St. John's-Wort (


Hypericum perforatum) 3X HPUS


The letters 'HPUS' indicate that the component in this product is officially monographed in the Homoeopathic Pharmacopoeia of the United States

Purpose

For aching back painFor pain while sittingFor pain along back of thighPain relieverFor leg and back painFor pain in the back of the legsFor back pain

​Use

For the temporary relief of pain in the lowerback, buttocks, and legs.

​Warnings

​For external use only.​A​void contact with eyes.

Stop Use And Ask A Doctor If

You experience worsening symptoms or if symptoms last longer than 7 days.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

​Directions

Generously apply and massage into skin from lower back to feet twice daily.

​Other Information

  • There is no scientific evidence that this product works.The product’s claims are based on theories of homeopathy from the 1700s that are not accepted by most modern medical experts.

​Inactive Ingredients

Aloe vera leaf juice, benzocaine, C13-14 isoparaffin, calendula flower extract, cayenne resin, cranesbill extract, dog rose flower extract, English lavender oil, European elder flower extract, fennel seed extract, folic acid, laurteth-7, magnesium ascorbyl phosphate, methylparaben, polyacrylamide, propylene glycol, propylparaben, retinyl palmitate, sage leaf extract, sage oil, tocopheryl acetate, bitter orange flower extract, water, yarrow extract

* Please review the disclaimer below.