NDC 61877-0007 Somaderm

Glandula Suprarenalis Suis, Thyroidinum (bovine), Hgh

NDC Product Code 61877-0007

NDC 61877-0007-1

Package Description: 96 g in 1 BOTTLE, PUMP

NDC Product Information

Somaderm with NDC 61877-0007 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.

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: 09-18-2019 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.

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:

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

Indications:

May Improve Bone and Joint Health*May Increase Muscle and Reduce Fat*May Improve Sleep**These statements have not been evaluated by the FDA

May Improve Bone and Joint Health*May Increase Muscle and Reduce Fat*May Improve Sleep**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 two full pumps in the morning and two full pumps in the evening: five days on, two days off. For intensive use, apply four full pumps in the morning, four 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. Store between 48-78 degrees, in a cool dry place away from sunlight.

Inactive Ingredients:

Purified Water, Phenoxyethanol & Caprylyl Glycol & Sorbic Acid, Aloe Barbadensis Leaf, Camellia Sinensis (Green Tea) Leaf, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycyrrhiza Glabra (Licorice) Root, Vitex Agnus-castus (Chaste Tree) Fruit, Epimedium Sagittatum (Epimedium) Leaf, Ginkgo Biloba (Ginkgo) Leaf, Mucuna Pruriens (Velvet Bean) Seed, Dioscorea Villosa (Wild Yam) Root, Sodium Hydroxide, Ascorbic Acid, Peg-33 (and) Peg-8 Dimethicone, (and) Peg-14, Aloe Vera Leaf Juice, Tocopherols (Soy), Edetate Disodium, Natural Plant Extract, Potassium Sorbate.

Questions:

Manufactured for:New U Life2623 Pleasant Hill Rd,Pleasant Hill, CA 945231.925.274.5000SOMADERMis a licensedtrademark of XygenyXTM

Package Label Display:

NEW U LIFESOMADERMMAXIMUM STRENGTHSOMATROPINHOMEOPATHICTRANSDERMAL GELNET WT 3.4oz (96g)

* Please review the disclaimer below.