Label: SOMADERM (glandula suprarenalis suis, thyroidinum- bovine, hgh gel
- NDC Code(s): 61877-0007-1
- 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 September 23, 2019
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
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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.
- INDICATIONS:
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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.
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- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
SOMADERM
glandula suprarenalis suis, thyroidinum (bovine), hgh gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61877-0007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND 6 [hp_X] in 1 g THYROID, BOVINE (UNII: MN18OTN73W) (THYROID, BOVINE - UNII:MN18OTN73W) THYROID, BOVINE 8 [hp_X] in 1 g SOMATROPIN (UNII: NQX9KB6PCL) (SOMATROPIN - UNII:NQX9KB6PCL) SOMATROPIN 30 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61877-0007-1 96 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 09/18/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/18/2019 Labeler - Natural Life Foods Corporation dba XYGENYX (825154537) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(61877-0007) , api manufacture(61877-0007) , label(61877-0007) , pack(61877-0007)
