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 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:

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:

Manufactured for:
New U Life
2623 Pleasant Hill Rd,
Pleasant Hill, CA 94523
1.925.274.5000


SOMADERM
is a licensed
trademark of XygenyXTM

PACKAGE LABEL DISPLAY:

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

Somatropin

SOMADERM 
glandula suprarenalis suis, thyroidinum (bovine), hgh gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61877-0007
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:61877-0007-196 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/18/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic09/18/2019
Labeler - Natural Life Foods Corporation dba XYGENYX (825154537)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(61877-0007) , api manufacture(61877-0007) , label(61877-0007) , pack(61877-0007)

Revised: 9/2019
Document Id: d76e3302-87d9-45d7-8079-bda24188ad77
Set id: 78032cc1-d529-4d04-8a5c-22fe67ad5ded
Version: 2
Effective Time: 20190923
 
Natural Life Foods Corporation dba XYGENYX