NDC 48951-1116 Arnica Betula B

Arnica Betula B

NDC Product Code 48951-1116

NDC 48951-1116-1

Package Description: 10 AMPULE in 1 BOX > 1 mL in 1 AMPULE

NDC Product Information

Arnica Betula B with NDC 48951-1116 is a a human over the counter drug product labeled by Uriel Pharmacy Inc.. The generic name of Arnica Betula B is arnica betula b. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Uriel Pharmacy Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 Betula B 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.

  • BETULA PUBESCENS LEAF 3 [hp_X]/mL
  • BETULA PUBESCENS BARK 4 [hp_X]/mL
  • BOS TAURUS CEREBELLUM 17 [hp_X]/mL
  • BOS TAURUS BRAIN 17 [hp_X]/mL
  • BOS TAURUS PINEAL GLAND 17 [hp_X]/mL
  • SUS SCROFA EAR 17 [hp_X]/mL
  • BOS TAURUS NERVE 17 [hp_X]/mL
  • ARNICA MONTANA 30 [hp_X]/mL
  • BIFENTHRIN 30 [hp_X]/mL
  • LEAD 30 [hp_X]/mL
  • HONEY 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.

  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

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: 12-31-2021 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.

Arnica Betula B Product Label Images

Arnica Betula B 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 ORAL USE.

Dosage & Administration

Take the contents of one ampule under the tongue and hold for 30 seconds, then swallow.

Otc - Active Ingredient

Active Ingredients: Betula e fol. (Silver birch leaves) 3X, Betula (cort.) dec. (Silver birch, bark dried) 4X, Cerebellum (Bovine cerebellum) 17X, Corpora quadrigemina (Bovine Quadrigeminal plate) 17X, Epiphysis (Bovine pineal body) 17X, Labyrinthus (Bovine inner ear) 17X, Medulla oblong. (ventr. quart.) (Bovine Myelencephalon ) 17X, Nervus statoacusticus (Bovine eighth cranial nerve) 17X, Arnica e pl. tota (Arnica) 30X, Onyx (Nat. Silicic acid with traces of iron oxide and carbon) 30X, Plumbum mellitum (Lead with honey) 30X

Inactive Ingredient

Inactive Ingredients: Water, Salt

Otc - Purpose

Use: Temporary relief of headache.

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN.

Warnings

Warnings: 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 or if conditions worsen or persist. If pregnant or nursing, consult a doctor before use.

Otc - Questions

Questions? Call 866.642.2858 Made by Uriel, East Troy, WI 53120 www.urielpharmacy.com

* Please review the disclaimer below.