SOMADERM- glandula suprarenalis suis, thyroidinum (bovine), hgh gel 
Natural Life Foods Corporation dba XYGENYX

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.

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Drug Facts:

ACTIVE INGREDIENTS:

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

INDICATIONS:

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:

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 one full pump in the morning and one full pump in the evening: five days on, two days off. For intensive use, apply two full pumps in the morning, two 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:

May Improve Bone and Joint Health*
May Increase Muscle and Reduce Fat*
May Improve Sleep*

*These statements have not been evaluated by the FDA

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.

QUESTIONS:

Distributed By:
New U Life
2638 Pleasant Hill Rd,
Pleasant Hill, CA 94523
1.844.510.6398

PACKAGE LABEL DISPLAY:

NEW U LIFE
SOMADERM
MAXIMUM STRENGTH
HOMEOPATHIC
SOMATROPIN
TRANSDERMAL GEL
NET WT 3.4oz (96g)

Somaderm

SOMADERM 
glandula suprarenalis suis, thyroidinum (bovine), hgh gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61877-0005
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:61877-0005-1100 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/20/201809/16/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/20/201809/16/2024
Labeler - Natural Life Foods Corporation dba XYGENYX (825154537)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(61877-0005) , api manufacture(61877-0005) , label(61877-0005) , pack(61877-0005)

Revised: 1/2023
Document Id: f737a40b-b962-46c4-9dd3-1f73bdb07c19
Set id: 49cee09a-e830-4d6c-9607-4d76797c9e68
Version: 6
Effective Time: 20230110
 
Natural Life Foods Corporation dba XYGENYX