NDC 0220-9070 Acteane

Arnica Montana, Black Cohosh, Nitroglycerin, Lachesis Muta Venom, Sanguinaria Canadensis Root

NDC Product Code 0220-9070

NDC CODE: 0220-9070

Proprietary Name: Acteane What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Arnica Montana, Black Cohosh, Nitroglycerin, Lachesis Muta Venom, Sanguinaria Canadensis Root What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
9 MM
Score: 1

NDC Code Structure

  • 0220 - Laboratoires Boiron

NDC 0220-9070-29

Package Description: 120 TABLET in 1 BOX

NDC Product Information

Acteane with NDC 0220-9070 is a a human over the counter drug product labeled by Laboratoires Boiron. The generic name of Acteane is arnica montana, black cohosh, nitroglycerin, lachesis muta venom, sanguinaria canadensis root. The product's dosage form is tablet and is administered via oral form.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Acteane 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.

  • LACTOSE (UNII: J2B2A4N98G)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SUCROSE (UNII: C151H8M554)

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: Laboratoires Boiron
Labeler Code: 0220
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: 09-01-2015 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 - 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".

* Please review the disclaimer below.

Acteane Product Label Images

Acteane 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 4C HPUS



Cimicifuga racemosa 4C HPUS



Glonoinum 4C HPUS



Lachesis mutus 5C HPUS



Sanguinaria canadensis 4C HPUS

Purpose

Arnica montana.......Relieves blotchy face associated with hot flashesCimicifuga racemosa.......Relieves irritability and occasional sleeplessness associated with menopauseGlonoinum.......Relieves sudden hot flashes with profuse sweating and throbbing headache associated with menopauseLachesis mutus.......Relieves irritability, hot flashes and night sweats associated with menopauseSanguinaria canadensis.......Relieves flushing of the face associated with menopause

Uses

• temporarily reduces the symptoms of menopause including the intensity and
frequency of hot flashes, night sweats and irritability.

Stop Use And Ask A Doctor

  • If symptoms persist for more than 1 month or worsen.

If Pregnant Or Breast-Feeding,

  • Ask a health professional before use.

Directions

  • Adults: Allow one tablet to slowly dissolve in the mouth 2 to 4 times throughout
  • The day or night, depending on the intensity of the symptoms. Daily use for three
  • Months is recommended.
  • Children: Not recommended.

Other Information

  • Do not use if glued carton end flaps or perforation is open, or if the blister seal is broken.
  • Based on four tablets per day, one box of Acteane, or 120 tablets, will provide a one-month supply.

Inactive Ingredients

Lactose, magnesium stearate, sucrose.

Principle Display Panel

120 tablet package

* Please review the disclaimer below.