Label: SOMADERM (glandula suprarenalis suis, thyroidinum- bovine, hgh gel
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Contains inactivated NDC Code(s)
NDC Code(s): 61877-0006-1 - 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 April 20, 2018
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
- KEEP OUT OF REACH OF CHILDREN:
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DIRECTIONS:
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.
- INDICATIONS:
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INACTIVE INGREDIENTS:
Purified Water, Aloe Vera Leaf, Green Tea (Leaf), Licorice (Root), Chaste Tree (Fruit), Epimedium (Leaf), Ginkgo (Leaf), Velvet Bean (Seed), Wild Yam (Root), Ascorbic Acid (Vitamin C), Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Peg-33 (and) Peg-8 Dimethicone, (and) Peg-14, Aloe Barbadensis Leaf Juice, Tocopherols (Soy), Disodium EDTA, Natural Plant Extract, Sodium Hydroxide and Potassium Sorbate.
- QUESTIONS:
- 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:61877-0006 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:61877-0006-1 100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 04/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/20/2018 Labeler - Natural Life Foods Corporation dba XYGENYX (825154537) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(61877-0006) , api manufacture(61877-0006) , label(61877-0006) , pack(61877-0006)