NDC 43857-0259 Strength M

Aralia Quinquefolia, Avena Sativa, Damaina, L-arginne, Epimedium, Glutathion, L-leucine, L-ornithine, Valine, Testosterone, Sabal Serrulata, Sepia,

NDC Product Code 43857-0259

NDC CODE: 43857-0259

Proprietary Name: Strength M 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: Aralia Quinquefolia, Avena Sativa, Damaina, L-arginne, Epimedium, Glutathion, L-leucine, L-ornithine, Valine, Testosterone, Sabal Serrulata, Sepia, 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medicated patch contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (e.g., hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels. Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire. This drug should not be used by women.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0259-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Strength M with NDC 43857-0259 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Strength M is aralia quinquefolia, avena sativa, damaina, l-arginne, epimedium, glutathion, l-leucine, l-ornithine, valine, testosterone, sabal serrulata, sepia, . The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, 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.

Strength M 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.

  • AMERICAN GINSENG 3 [hp_X]/mL
  • AVENA SATIVA FLOWERING TOP 3 [hp_X]/mL
  • TURNERA DIFFUSA LEAFY TWIG 3 [hp_X]/mL
  • ARGININE 6 [hp_X]/mL
  • EPIMEDIUM GRANDIFLORUM TOP 6 [hp_X]/mL
  • GLUTATHIONE 6 [hp_X]/mL
  • LEUCINE 6 [hp_X]/mL
  • ORNITHINE 6 [hp_X]/mL
  • VALINE 6 [hp_X]/mL
  • TESTOSTERONE 12 [hp_X]/mL
  • SAW PALMETTO 24 [hp_X]/mL
  • SEPIA OFFICINALIS JUICE 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)
  • 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.
  • 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: Bioactive Nutritional, Inc.
Labeler Code: 43857
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: 06-17-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 11-10-2020 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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’.

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Strength M Product Label Images

Strength M 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:

Aralia Quinquefolia 3X, Avena Sativa 3X, Damiana 3X, L-Arginine 6X, Epimedium 6X, Glutathione 6X, L-Leucine 6X, L-Ornithine 6X, Valine 6X, Testosterone 12X, Sabal Serrulata 24X, Sepia 30X.

Indications:

For temporary relief of muscular exhaustion, debility after exercise and lowered vitality in the male after exercise.

For temporary relief of muscular exhaustion, debility after exercise and lowered vitality in the male after exercise.

Warnings:

If pregnant or breast-feeding, ask a health care professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.Do not use if tamper evident seal is broken or missing.Store in cool, dry place.

Keep Out Of Reach Of Children:

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

Directions:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol.

Questions:

Distributed by:BIOACTIVE NUTRITIONALMelbourne, FL 32935For Nutritional Information write:BioActive Nutritional, Inc.1803 N. Wickham Rd.Melbourne, FL 32935

Package Label Display:

BioActive HomeopathicSTRENGTH M1 FL OZ (30 ml)

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