Somaderm AWE

Manufacturer
Natural Life Foods Corporation dba XYGENYX
Effective date
2023-12-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:15

Label at a glance#

ProductSomaderm AWE
Active ingredientSOMATROPIN, THYROID, BOVINE, SUS SCROFA ADRENAL GLAND
Label structure11 sections

Storage and handling

Store in a cool dry place away from direct sunlight.

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

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)

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

WARNING: KEEP OUT OF REACH OF CHILDREN

If 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 ONLY

Sealed for your protection.

Do not use if seal has been broken or tampered with.

INSTRUCTIONS FOR USE SECTION

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.

OTC - QUESTIONS SECTION

QUESTIONS:

Distributed By:
XYGENYX
2638 Pleasant Hill Rd,
Pleasant Hill, CA 94523
1-844-510-6398

OTC - ACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

Use two pumps to apply a thin layer of Samderm AQW to areas experiencing discomfort. Apply two pumps in the morning and two pumps in the evening. It is best to apply Somaderm AWE after showering. Store in a cool dry place from direct sunlight.

STORAGE AND HANDLING SECTION

Store in a cool dry place away from direct sunlight.

OTC - PURPOSE SECTION

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 SECTION

LabelLabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabelLabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
79c101e4-e5e3-43d7-be20-f7477d1e7556Product name120241230
34b7b043-6d89-4d95-9bed-7f5f2b49e6efProduct name220200325
37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04Product name220200325
739a54c2-5f56-495a-aa67-4295fbc1cc86Product name220200325

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61877-0008-1Somaderm AWE1 in 1 BOXGEL12
61877-0008-1Somaderm AWE48 g in 1 BOTTLE, PUMPGEL482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61877-0008SOMADERM AWE (GLANDULA SUPRARENALIS SUIS, THYROIDINUM (BOVINE), HGH) GEL [NATURAL LIFE FOODS CORPORATION DBA XYGENYX]22 package rows20231228_fab8878c-12b4-6f9e-e053-6394a90a82fe.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61877-000861877-0008-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0d854b5f-506f-cdb6-e063-6394a90a2adefab8878c-12b4-6f9e-e053-6394a90a82fe2023-12-27WarningsExact identifier
spl id: 0d854b5f-506f-cdb6-e063-6394a90a2ade
spl set id: fab8878c-12b4-6f9e-e053-6394a90a82fe

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.