NDC 61877-0005 Somaderm

Glandula Suprarenalis Suis, Thyroidinum (bovine), Hgh

NDC Product Code 61877-0005

NDC CODE: 61877-0005

Proprietary Name: Somaderm 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: Glandula Suprarenalis Suis, Thyroidinum (bovine), Hgh 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.

  • Various brands of this medication are used for the treatment of one of the following medical conditions: growth failure, growth hormone deficiency, intestinal disorder (short bowel syndrome) or HIV-related weight loss or wasting. Somatropin is also used to increase height in children with certain disorders (such as Noonan syndrome, Turner syndrome, idiopathic short stature).

NDC Code Structure

  • 61877 - Natural Life Foods Corporation Dba Xygenyx

NDC 61877-0005-1

Package Description: 100 g in 1 BOTTLE, PUMP

NDC Product Information

Somaderm with NDC 61877-0005 is a a human over the counter drug product labeled by Natural Life Foods Corporation Dba Xygenyx. The generic name of Somaderm is glandula suprarenalis suis, thyroidinum (bovine), hgh. The product's dosage form is gel and is administered via topical form.

Labeler Name: Natural Life Foods Corporation Dba Xygenyx

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Somaderm 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.

  • SUS SCROFA ADRENAL GLAND 6 [hp_X]/g
  • THYROID, BOVINE 8 [hp_X]/g
  • SOMATROPIN 30 [hp_X]/g

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)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SORBIC ACID (UNII: X045WJ989B)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • LICORICE (UNII: 61ZBX54883)
  • CHASTE TREE (UNII: 433OSF3U8A)
  • EPIMEDIUM SAGITTATUM TOP (UNII: 7G8Y7M4D58)
  • GINKGO (UNII: 19FUJ2C58T)
  • MUCUNA PRURIENS SEED (UNII: 55G8SQ543S)
  • DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • OREGANO (UNII: 0E5AT8T16U)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Natural Life Foods Corporation Dba Xygenyx
Labeler Code: 61877
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: 04-20-2018 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.

Somaderm Product Label Images

Somaderm 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:

Glandula Suprarenalis Suis 6X, Thyroidinum (Bovine) 8X, Somatropin 30X.

Indications:

MAY IMPROVE BONE AND JOINT HEALTH*MAY INCREASE MUSCLE AND REDUCE FAT*MAY IMPROVE SLEEP*MAY STRENGTHEN THE IMMUNE SYSTEM**These statements have not been evaluated by the FDA

MAY IMPROVE BONE AND JOINT HEALTH*MAY INCREASE MUSCLE AND REDUCE FAT*MAY IMPROVE SLEEP*MAY STRENGTHEN THE IMMUNE SYSTEM**These statements have not been evaluated by the FDA

Warnings:

WARNING: KEEP OUT OF REACH OF CHILDRENIf swallowed, get medical help or contact a Poison Control Center right away.If pregnant or breast-feeding, ask a health professional before use.FOR EXTERNAL USE ONLYSealed for your protection.Do not use if seal has been broken or tampered with.

Keep Out Of Reach Of Children:

KEEP OUT OF REACH OF CHILDREN.If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Apply 1 full pump in the morning and 1 full pump in the evening: 5 days on, 2 days off. For intensive use, apply 2 full pumps in the morning, 2 full pumps in the evening.Gel should always be applied to the thin areas of skin, wherever veins are visible. You may apply the gel to your underarms, forearms, wrists and behind the knees. Applied locations should be rotated.

Inactive Ingredients:

Purified Water, Aloe Vera Leaf, Green Tea (Leaf), Licorice (Root), Chaste Tree (Fruit), Epimedium (Leaf), Ginkgo (Leaf), Velvet Bean (Seed), Wild Yam (Root), Ascorbic Acid (Vitamin C), Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Peg-33 (and) Peg-8 Dimethicone, (and) Peg-14, Aloe Barbadensis Leaf Juice, Tocopherols (Soy), Disodium EDTA, Natural Plant Extract, Sodium Hydroxide and Potassium Sorbate.

Questions:

Distributed By:XYGENYX2638 Pleasant Hill Rd,Pleasant Hill, CA 945231-844-510-6398

Package Label Display:

NEW U LIFESOMADERMGel TRANSDERMALMAXIMUM STRENGTHHOMEOPATHICHUMAN GROWTH HORMONEPARABEN AND SLS FREENET WT. 3.5 OZ (100G)

* Please review the disclaimer below.