NDC 61096-1032 Arnica Power

Arnica Montana

NDC Product Code 61096-1032

NDC 61096-1032-1

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 41 mL in 1 BOTTLE, SPRAY

NDC Product Information

Arnica Power with NDC 61096-1032 is a a human over the counter drug product labeled by Eight And Company L.l.c. The generic name of Arnica Power is arnica montana. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Eight And Company L.l.c

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 Power 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.

  • ARNICA MONTANA 3 [hp_X]/41mL

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: Eight And Company L.l.c
Labeler Code: 61096
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: 03-08-2019 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: 12-31-2020 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 Power Product Label Images

Arnica Power 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 Ingredient: Arnica montana 3X, 4X, 6X

Warnings

Warnings: If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions: Adults and children over 12: 2 sprays under the tongue 3 times per day. For additional symptom relief spray directly  on the affected area and massage gently into the skin. Repeat 3 times a day or as needed. Ages 2-12: 1 spray under the tongue 3 times per day. For additional symptom relief, spray directly on the affected area 3 times per day. Under age 2: consult a doctor prior to use.

Otc - Purpose

  • Temporarily relieves symptoms associated with overexertion or trauma, such as:muscle achesstiffnessswelling from injuriesbruising

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Glycerin 10% v/v, non-GMO organic alcohol 9% v/v, purified water.

Indications & Usage

  • Temporarily relieves symptoms associated with overexertion or trauma, such as:muscle achesstiffnessswelling from injuriesbruising° natural° gluten free° no artificial flavors or colors° vegan° no known negative side effects° no known negative drug interactions

* Please review the disclaimer below.