NDC 71880-0002 Healexir

Arnica Montana

NDC Product Code 71880-0002

NDC 71880-0002-1

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Healexir with NDC 71880-0002 is a a human over the counter drug product labeled by Healexir, Llc. The generic name of Healexir is arnica montana. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Healexir, Llc

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.

Healexir 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 1 [hp_M]/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)
  • ALCOHOL (UNII: 3K9958V90M)

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: Healexir, Llc
Labeler Code: 71880
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: 08-30-2019 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.

Healexir Product Label Images

Healexir 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:

Arnica Montana 1M.

Purpose:

May relieve symptoms associated with temporary bruising and swelling as a result of cosmetic injections.****Statements are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Warnings:

•Consult a physician if symptoms persist•Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.•Use only as directed.•Do not use if you have an allergy to any of the ingredients listed.•If pregnant or nursing, ask a doctor prior to use of product.•Do not use if TAMPER EVIDENT seal around neck of bottle is missing or broken.•Store at room temperature.

Keep Out Of Reach Of Children:

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

•Spray single pump into mouth at these intervals:•Take every 15 minutes (while awake) for first 48 hours following procedure.•Take every hour (while awake) for the next 48 hours.•Take every 2 hours for the following 5 days.•Take 3 times a day for the next 5 days.•Consult a physician for use in children under 12 years of age.

Indications:

May relieve symptoms associated with temporary bruising and swelling as a result of cosmetic injections.****Statements are based on traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Inactive Ingredients:

20% Organic Alcohol v/v, Purified water

Questions:

Distributed byHealexir, LLC. Santa Fe, New Mexico 87505www.healexir.com  917-568-7777

Package Label Display:

HEALEXIRholistic recoveryHomeopathic1 fluid ounce (30ml)

* Please review the disclaimer below.