Label: SOMADERM (glandula suprarenalis suis, thyroidinum- bovine, hgh gel

  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS:

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

  • INDICATIONS:

    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

  • WARNINGS:

    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.

  • KEEP OUT OF REACH OF CHILDREN:

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • 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:

    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

  • 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:

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

  • PACKAGE LABEL DISPLAY:

    Platinum Series
    STRIKEFIRST
    NUTRITION

    SOMADERM
    Gel TRANSDERMAL
    MAXIMUM STRENGTH
    HOMEOPATHIC
    HUMAN GROWTH HORMONE
    PARABEN AND SLS FREE
    NET WT. 3.5 OZ (100G)

    Somaderm

  • INGREDIENTS AND APPEARANCE
    SOMADERM 
    glandula suprarenalis suis, thyroidinum (bovine), hgh gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61877-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SUS SCROFA ADRENAL GLAND (UNII: 398IYQ16YV) (SUS SCROFA ADRENAL GLAND - UNII:398IYQ16YV) SUS SCROFA ADRENAL GLAND6 [hp_X]  in 1 g
    THYROID, BOVINE (UNII: MN18OTN73W) (THYROID, BOVINE - UNII:MN18OTN73W) THYROID, BOVINE8 [hp_X]  in 1 g
    SOMATROPIN (UNII: NQX9KB6PCL) (SOMATROPIN - UNII:NQX9KB6PCL) SOMATROPIN30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61877-0006-1100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/20/2018
    Labeler - Natural Life Foods Corporation dba XYGENYX (825154537)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(61877-0006) , api manufacture(61877-0006) , label(61877-0006) , pack(61877-0006)