NDC 43846-0073 Muscle Ice

Phytolacca Decandra, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Symphytum Officinale, Magnesia Phosphorica, Silicea, Menthol (crystals)

NDC Product Code 43846-0073

NDC CODE: 43846-0073

Proprietary Name: Muscle Ice 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, Bellis Perennis, Ledum Palustre, Ruta Graveolens, Symphytum Officinale, Magnesia Phosphorica, Silicea, Menthol (crystals) 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 43846-0073-1

Package Description: 57 g in 1 TUBE

NDC Product Information

Muscle Ice with NDC 43846-0073 is a a human over the counter drug product labeled by Peaceful Mountain, Inc.. The generic name of Muscle Ice is phytolacca decandra, bellis perennis, ledum palustre, ruta graveolens, symphytum officinale, magnesia phosphorica, silicea, menthol (crystals). 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.

Muscle Ice 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
  • BELLIS PERENNIS 6 [hp_X]/g
  • LEDUM PALUSTRE TWIG 6 [hp_X]/g
  • RUTA GRAVEOLENS FLOWERING TOP 6 [hp_X]/g
  • COMFREY ROOT 6 [hp_X]/g
  • MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 9 [hp_X]/g
  • SILICON DIOXIDE 9 [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.

  • MENTHOL (UNII: L7T10EIP3A)
  • WATER (UNII: 059QF0KO0R)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SORBIC ACID (UNII: X045WJ989B)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SPANISH THYME OIL (UNII: U14667H96E)
  • GINGER OIL (UNII: SAS9Z1SVUK)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • HYPERICUM OIL (UNII: OZU2FC70HY)
  • ALCOHOL (UNII: 3K9958V90M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)

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: 03-20-2020 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 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.

Muscle Ice Product Label Images

Muscle Ice 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 gel): 4% of Menthol; 0.20% of Bellis 6X, Ledum Palustre 6X, Phytolacca Decandra 4X, Ruta Graveolens 6X, Symphytum Officinale 6X; 0.001% of Magnesia Phosphorica 9X, Silicea 9X.

Indications:

May temporarily relieve minor aches and pains of muscles and joints.****Claims based on traditional homeopathic principles, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve minor aches and pains of muscles and joints.****Claims based on traditional homeopathic principles, not accepted medical evidence. Not FDA evaluated.

Warnings:

For external use only. Avoid contact with eyes.If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.Do not apply to wounds or damaged skin, or mucous membranes. Do not bandage tightly.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 use if saftey 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:

Adults:Apply to affected area not more than 3 to 4 times daily.Children2 years of age and older: Consult a health professional. Do not use on children under 2 years of age.

Inactive Ingredients:

Purified Water, Aloe Vera Leaf Juice, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, PEG-33, PEG-8 Dimethicone, PEG-14, Sodium Hydroxide (Solution), Tocopherols (Derived from Soy Bean), EDETATE Disodium (EDTA), Ginger (Zingiber Officinale) Root Oil, English Lavender (Lavandula Angustifolia) Flower Oil, Spanish Thyme (Thymus Zygis) Aerial Parts Oil, St. John’s Wort (Hypericum Perforatum) Aerial Parts Oil, Potassium Sorbate, Sodium Benzoate, Ethanol and Citric Acid.

Questions

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

Package Label Display:

Muscle icepeaceful mountainTHE HEIGHT OF HEALTHhomeopathicpain relieving gelparaben-freeNet wt. 2 oz (57 g)

* Please review the disclaimer below.