NDC 57520-0309 Arnica Plus

Arnica Montana, Hamamelis Virginiana, Rhus Toxicodendron,

NDC Product Code 57520-0309

NDC 57520-0309-1

Package Description: 100 g in 1 TUBE

NDC Product Information

Arnica Plus with NDC 57520-0309 is a a human over the counter drug product labeled by Apotheca Company. The generic name of Arnica Plus is arnica montana, hamamelis virginiana, rhus toxicodendron, . The product's dosage form is gel and is administered via topical form.

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.

Arnica Plus 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.


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)
  • ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
  • CARBOMER INTERPOLYMER TYPE A (55000 MPA.S)) (UNII: 59TL3WG5CO)
  • WATER (UNII: 059QF0KO0R)
  • HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ)
  • SAGE (UNII: 065C5D077J)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • MENTHA PIPERITA LEAF (UNII: A389O33LX6)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SORBIC ACID (UNII: X045WJ989B)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)

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: Apotheca Company
Labeler Code: 57520
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: 03-15-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 04-06-2023 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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".

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Arnica Plus Product Label Images

Arnica Plus 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

Otc - Active Ingredient

ACTIVE INGREDIENTS:  Arnica montana 6X, 12X, Hamamelis virginiana 6X, 12X, Rhus toxicodendron 6X, 12X.

Otc - Purpose

INDICATIONS:  For temporary relief of minor symptoms of sore, overexerted muscles.

Warnings

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.

Dosage & Administration

DIRECTIONS:  Apply at least 3 times daily over the affected area.

Inactive Ingredient

INACTIVE INGREDIENTS:  Aloe vera concentrate, Arnica montana flower, Carbomer, Demineralized water, Devil's claw root, Edetate disodium, Oregano, Sage, PEG-33, PEG-8, Dimethicone, PEG-14, Peppermint leaf, Phenoxyethanol, Caprylyl glycol, Sorbid acid, Potassium sorbate, Sodium hydroxide, Vitamin C, Vitamin E oil, White willow bark, Witch hazel bark.

Otc - 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.

Indications & Usage

INDICATIONS:  For temporary relief of minor symptoms of sore, overexerted muscles.

Otc - Questions

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

* Please review the disclaimer below.