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

Somaderm by

Drug Labeling and Warnings

Somaderm by is a Homeopathic medication manufactured, distributed, or labeled by Natural Life Foods Corporation dba XYGENYX, Apotheca Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

SOMADERM 
glandula suprarenalis suis, thyroidinum (bovine), hgh gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61877-0005
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: 61877-0005-1	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(61877-0005) , api manufacture(61877-0005) , label(61877-0005) , pack(61877-0005)