NDC 48951-1311 Aquilinum Taraxacum

Aquilinum Taraxacum

NDC Product Code 48951-1311

NDC Product Information

Aquilinum Taraxacum with NDC 48951-1311 is a a human over the counter drug product labeled by Uriel Pharmacy Inc.. The generic name of Aquilinum Taraxacum is aquilinum taraxacum. The product's dosage form is cream and is administered via topical form.

Labeler Name: Uriel Pharmacy 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.

Aquilinum Taraxacum 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.

  • TARAXACUM PALUSTRE ROOT 3 [hp_X]/g
  • ASPLENIUM SCOLOPENDRIUM TOP 3 [hp_X]/g
  • WILLOW BARK 3 [hp_X]/g
  • DRYOPTERIS FILIX-MAS ROOT 3 [hp_X]/g
  • SOLIDAGO CANADENSIS FLOWERING TOP 3 [hp_X]/g
  • PTERIDIUM AQUILINUM WHOLE 3 [hp_X]/g
  • CHELIDONIUM MAJUS 3 [hp_X]/g
  • SALIX PURPUREA BARK 3 [hp_X]/g
  • SALIX ALBA FLOWER 3 [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.

  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CITRUS PARADISI SEED (UNII: 12F08874Y7)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • WATER (UNII: 059QF0KO0R)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • MYRRH OIL (UNII: H74221J5J4)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • SORBIC ACID (UNII: X045WJ989B)

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: Uriel Pharmacy Inc.
Labeler Code: 48951
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: 09-01-2009 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.

Aquilinum Taraxacum Product Label Images

Aquilinum Taraxacum 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

Indications & Usage

Directions: FOR TOPICAL USE ONLY.

Dosage & Administration

Apply to skin as needed. Under age 2: Consult a doctor.

Otc - Active Ingredient

Active Ingredients: Chelidonium (Greater celandine) 3X, Filix (Male fern) 3X, Pteridium (Eagle fern) 3X, Salix purp. (Purple willow) 3X, Salix vim. (Osier willow) 3X, Salix vite. (Golden willow) 3X, Scolopendrium (Hart’s tongue) 3X, Solidago virg. (Goldenrod) 3X, Taraxacum (Dandelion) 3X

Inactive Ingredient

Inactive Ingredients: Distilled water, Stearic acid, Isopropyl myristate, Lavender oil, Cetyl alcohol, Polyoxyl 40 stearate, Steryl alcohol, Xanthan gum, Frankincense oil, Myrrh oil, Sorbic acid, Tea tree oil, Grapefruit seed extract

Otc - Purpose

Use: Temporary relief of digestive upset.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: FOR EXTERNAL USE ONLY.

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated. Do not use if allergic to any ingredient. Consult a doctor before use for serious conditions, if conditions worsen or persist, or accidental ingestion occurs. If pregnant or nursing, consult a doctor before use. Avoid contact with eyes. Do not use if safety seal is broken or missing.

Otc - Questions

Questions? Call 866.642.2858

Made with care by Uriel, East Troy, WI 53120

www.urielpharmacy.com

* Please review the disclaimer below.

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