SPL v2
SPL
SPL Set ID fab8878c-12b4-6f9e-e053-6394a90a82fe
Route
TOPICAL
Published
Effective Date 2023-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Somatropin (30 [hp_X]) Thyroid, Bovine (8 [hp_X]) Sus Scrofa Adrenal Gland (6 [hp_X])
Inactive Ingredients
Water Arnica Montana Flower Aloe Vera Leaf Licorice Vitex Agnus-castus Leaf Ginkgo Biloba Whole Dioscorea Villosa Root Caprylyl Glycol Ascorbic Acid Peg-14 Dimethicone Aloe Tocopherol Potassium Sorbate Eucalyptus Oil Polyethylene Glycol 100000 Willow Bark Phenoxyethanol Sorbic Acid Copaiba Oil Green Tea Leaf Epimedium Sagittatum Leaf Edetate Disodium Mentha Piperita Polysorbate 80 Mucuna Pruriens Seed Sodium Hydroxide Ethylene Oxide

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-05-04 Until 2026-05-31

Description

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)


Medication Information

Warnings and Precautions

Indications and Usage

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 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

Dosage and Administration

Use two pumps to apply a thin layer of Samderm AQW to areas experiencing discomfort. Apply two pumps in the morning and two pumps in the evening. It is best to apply Somaderm AWE after showering. Store in a cool dry place from direct sunlight.

Description

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)

Section 44425-7

Store in a cool dry place away from direct sunlight.

Section 50565-1

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.

Section 51727-6

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)

Section 51945-4

Section 53413-1

QUESTIONS:



Distributed By:

XYGENYX

2638 Pleasant Hill Rd,

Pleasant Hill, CA 94523

1-844-510-6398

Section 55105-1

May Improve Bone and Joint Health*May Increase Muscle and Reduce Fat*May Improve Sleep**These statements have not been evaluated by the FDA May Improve Bone and Joint Health*May Increase Muscle and Reduce Fat*May Improve Sleep**These statements have not been evaluated by the FDA

Section 55106-9

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

Section 59845-8

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.


Structured Label Content

Indications and Usage (34067-9)

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 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

Dosage and Administration (34068-7)

Use two pumps to apply a thin layer of Samderm AQW to areas experiencing discomfort. Apply two pumps in the morning and two pumps in the evening. It is best to apply Somaderm AWE after showering. Store in a cool dry place from direct sunlight.

Warnings and Precautions (34071-1)

Section 44425-7 (44425-7)

Store in a cool dry place away from direct sunlight.

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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)

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

QUESTIONS:



Distributed By:

XYGENYX

2638 Pleasant Hill Rd,

Pleasant Hill, CA 94523

1-844-510-6398

Section 55105-1 (55105-1)

May Improve Bone and Joint Health*May Increase Muscle and Reduce Fat*May Improve Sleep**These statements have not been evaluated by the FDA May Improve Bone and Joint Health*May Increase Muscle and Reduce Fat*May Improve Sleep**These statements have not been evaluated by the FDA

Section 55106-9 (55106-9)

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

Section 59845-8 (59845-8)

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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)