New U Life’s Homeopathic SOMADERM Gel is the ONLY transdermal human growth hormone (HGH) product available without a prescription.
NOTE: Keep out of reach of children.
GLANDULA SUPRARENALIS SUIS 6x, THYROIDINUM 8x, SOMATROPIN 30x
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 AGNUSCASTUS (CHASTE TREE) FRUIT*, EPIMEDIUM SAGITTATUM (EPIMEDIUM) AERIAL PARTS*, GINKGO BILOBA (GINKGO) LEAF*, MUCUNA PRURIENS (VELVET BEAN) SEED*, DIOSCOREA VILLOSA (WILD YAM) ROOT*, SODIUM HYDROXIDE*, ASCORBIC ACID*, PEG-33 & PEG-8 DIMETHICONE & PEG-14*, ALOE BARBADENSIS LEAF JUICE*, TOCOPHEROLS (Soy)*, EDETATE DISODIUM*, NATURAL PLANT EXTRACT*, POTASSIUM SORBATE **EXTRACT*
REGULATORY COMPLIANCE New U Life exclusively uses an FDA registered manufacturing facility and we comply with all FDA regulations. With our extensive experience in regulatory compliance of over-the-counter products, we can advise and assist with all requirements for FDA product indications, label copy, and ingredient listings. We also file the appropriate drug product listing with the FDA for all drug products manufactured for U.S. sales.
PRODUCT CONSISTENCY & RELIABILITY
According to FDA instruction, New U Life documents every step of the manufacturing operation. We consistently produce products by using quality raw materials, applying strict product testing, and by using standardized manufacturing processes with each and every order.
Through our worldwide channel of ethical and reliable suppliers, we are able to acquire quality, raw ingredients. We use a USP state-of-the-art water purifying system for all of our non GMO, gluten free, organic alcohol.
QUALITY CONTROL TESTING
A quarantine of all inbound raw materials is mandatory until the quality and identity of those raw materials are verified. All raw material suppliers must provide Certificates of Analysis. During the manufacturing process, all water used undergoes microbiological testing in accordance with USP (United States Pharmacopeia) regulations. It is not until an extensive series of product testing is performed before the product is released.
We use one of a small number of authorized homeopathic manufacturing facilities in the United States. New U Life is registered with and subject to inspection by the Food and Drug Administration (FDA). We follow all current good manufacturing practices (cGMPs) as set forth by the FDA.
SOMADERM™ Gel (NDC #61877-0005-1) is proudly the only homeopathic transdermal, over-the-counter, human growth hormone product available without prescription.
WHAT EXACTLY IS AN NDC?
The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. Drug products are identiﬁed and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identiﬁer for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily. The information submitted as part of the listing process, the NDC number, and the NDC Directory are used in the implementation and enforcement of the Act.