NDC 43742-1300 Hormone Combination

Salsolinol (hydrochloride), Cholesterinum, Dhea (dehydroepiandrosterone), 7-oxo- Dehydroepiandrosterone 3-acetate, Folliculinum, Oophorinum (suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone

NDC Product Code 43742-1300

NDC CODE: 43742-1300

Proprietary Name: Hormone Combination 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: Salsolinol (hydrochloride), Cholesterinum, Dhea (dehydroepiandrosterone), 7-oxo- Dehydroepiandrosterone 3-acetate, Folliculinum, Oophorinum (suis), Progesterone, Testosterone, Cortisone Aceticum, Aldosterone, Androsterone, Follicle Stimulating Hormone 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.

  • Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus). Progesterone must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.
  • 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.
  • Cortisone is a corticosteroid hormone (glucocorticoid). It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions. This medication is used to treat conditions such as arthritis, blood/hormone/immune system disorders, allergic reactions, certain skin and eye conditions, breathing problems, and certain cancers.

NDC Code Structure

  • 43742 - Deseret Biologicals, Inc.

NDC 43742-1300-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Hormone Combination with NDC 43742-1300 is a a human over the counter drug product labeled by Deseret Biologicals, Inc.. The generic name of Hormone Combination is salsolinol (hydrochloride), cholesterinum, dhea (dehydroepiandrosterone), 7-oxo- dehydroepiandrosterone 3-acetate, folliculinum, oophorinum (suis), progesterone, testosterone, cortisone aceticum, aldosterone, androsterone, follicle stimulating hormone. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Deseret Biologicals, 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.

Hormone Combination 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.

  • SALSOLINOL HYDROCHLORIDE, (+/-)- 6 [hp_X]/mL
  • PRASTERONE 6 [hp_X]/mL
  • 7-KETO-DEHYDROEPIANDROSTERONE 8 [hp_X]/mL
  • CHOLESTEROL 8 [hp_X]/mL
  • ESTRONE 8 [hp_X]/mL
  • SUS SCROFA OVARY 8 [hp_X]/mL
  • PROGESTERONE 8 [hp_X]/mL
  • TESTOSTERONE 8 [hp_X]/mL
  • CORTISONE ACETATE 12 [hp_X]/mL
  • ALDOSTERONE 12 [hp_C]/mL
  • ANDROSTERONE 12 [hp_C]/mL
  • FOLLITROPIN 12 [hp_C]/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: Deseret Biologicals, Inc.
Labeler Code: 43742
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: 06-29-2018 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.

Hormone Combination Product Label Images

Hormone Combination 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:

Salsolinol 6X, 12X, 30X, 200X, DHEA (Dehydroepiandrosterone) 6X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, 7-Oxo-Dehydroepiandrosterone 3β-Acetate, 8X, 12X, 30X, 60X, 200X, 12C, 30C, 60C, 200C, Folliculinum 8X, 12X, 30X, 60X, 200X, 12C, 30C, 60C, 200C, Oophorinum (Suis) 8X, 12X, 30X, 60X, 12C, 30C, 60C, 200C, Cholesterinum 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Progesterone 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Testosterone 8X, 12X, 30X, 200X, 12C, 30C, 60C, 200C, Cortisone Aceticum 12X, 30X, 200X, 12C, 30C, 60C, 200C, Aldosterone 12C, 30C, 60C, 200C, Androsterone 12C, 30C, 60C, 200C, Follicle Stimulating Hormone 12C, 30C, 60C, 200C.

Homeopathic Indications:

For temporary relief of symptoms related to hormone imbalances of insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females), and lack of libido.****These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

For temporary relief of symptoms related to hormone imbalances of insufficiencies in men and women, including low energy, inability to handle stress, trouble focusing, changes in mood, infertility, irregular menstrual cycles (females), and lack of libido.****These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

Warnings:

Keep out of reach of children. In case of overdose, contact a physician or Poison Control Center right away.If pregnant or breast-feeding, ask a health professional before use.Tamper Seal: "Sealed for Your Protection."Do not use if seal is broken or missing.

Keep Out Of Reach Of Children:

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

Directions:

1-10 drops under the tongue, 3 times a day or as directed by a health professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized Water, 25% Ethanol

Questions:

Dist. By: Deseret Biologicals, Inc.469 W. Parkland DriveSandy, UT 84070 www.desbio.com

Package Label Display:

DESBIONDC 43742-1300-1HOMEOPATHICHORMONECOMBINATION1 FL OZ (30 ml)

* Please review the disclaimer below.