Label: SOMADERM AWE (glandula suprarenalis suis, thyroidinum- bovine, hgh gel
- NDC Code(s): 61877-0008-1
- Packager: Natural Life Foods Corporation dba XYGENYX
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated December 27, 2023
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INACTIVE INGREDIENT
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
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
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INSTRUCTIONS FOR USE
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.
- QUESTIONS
- ACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- PURPOSE
- WARNINGS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOMADERM AWE
glandula suprarenalis suis, thyroidinum (bovine), hgh gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61877-0008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SOMATROPIN (UNII: NQX9KB6PCL) (SOMATROPIN - UNII:NQX9KB6PCL) SOMATROPIN 30 [hp_X] in 1 g THYROID, BOVINE (UNII: MN18OTN73W) (THYROID, BOVINE - UNII:MN18OTN73W) THYROID, BOVINE 8 [hp_X] in 1 g SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ALOE VERA LEAF (UNII: ZY81Z83H0X) LICORICE (UNII: 61ZBX54883) VITEX AGNUS-CASTUS LEAF (UNII: W4U9Y3Q5SR) GINKGO BILOBA WHOLE (UNII: 660486U6OI) DIOSCOREA VILLOSA ROOT (UNII: IWY3IWX2G8) CAPRYLYL GLYCOL (UNII: 00YIU5438U) ASCORBIC ACID (UNII: PQ6CK8PD0R) PEG-14 DIMETHICONE (UNII: G7DL1Y4G26) ALOE (UNII: V5VD430YW9) TOCOPHEROL (UNII: R0ZB2556P8) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EUCALYPTUS OIL (UNII: 2R04ONI662) POLYETHYLENE GLYCOL 100000 (UNII: V46Y6OJ5QB) WILLOW BARK (UNII: S883J9JDYX) PHENOXYETHANOL (UNII: HIE492ZZ3T) SORBIC ACID (UNII: X045WJ989B) COPAIBA OIL (UNII: 64VX45Y68N) GREEN TEA LEAF (UNII: W2ZU1RY8B0) EPIMEDIUM SAGITTATUM LEAF (UNII: 8H775CGY31) EDETATE DISODIUM (UNII: 7FLD91C86K) MENTHA PIPERITA (UNII: 79M2M2UDA9) POLYSORBATE 80 (UNII: 6OZP39ZG8H) MUCUNA PRURIENS SEED (UNII: 55G8SQ543S) SODIUM HYDROXIDE (UNII: 55X04QC32I) ETHYLENE OXIDE (UNII: JJH7GNN18P) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61877-0008-1 1 in 1 BOX 05/04/2023 1 48 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/04/2023 05/31/2026 Labeler - Natural Life Foods Corporation dba XYGENYX (825154537)
