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NDC 61877-0007-01 Somaderm 30; 6; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g Details
Somaderm 30; 6; 8 [hp_X]/g; [hp_X]/g; [hp_X]/g
Somaderm is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Natural Life Foods Corporation dba XYGENYX. The primary component is SOMATROPIN; SUS SCROFA ADRENAL GLAND; THYROID, BOVINE.
Product Information
| NDC | 61877-0007 |
|---|---|
| Product ID | 61877-0007_d76e3302-87d9-45d7-8079-bda24188ad77 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Somaderm |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Glandula Suprarenalis Suis, Thyroidinum (Bovine), HGH |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | GEL |
| Route | TOPICAL |
| Active Ingredient Strength | 30; 6; 8 |
| Active Ingredient Units | [hp_X]/g; [hp_X]/g; [hp_X]/g |
| Substance Name | SOMATROPIN; SUS SCROFA ADRENAL GLAND; THYROID, BOVINE |
| Labeler Name | Natural Life Foods Corporation dba XYGENYX |
| Pharmaceutical Class | Human Growth Hormone [CS], Recombinant Human Growth Hormone [EPC] |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED HOMEOPATHIC |
| Application Number | n/a |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 61877-0007-01 (61877000701)
| NDC Package Code | 61877-0007-1 |
|---|---|
| Billing NDC | 61877000701 |
| Package | 96 g in 1 BOTTLE, PUMP (61877-0007-1) |
| Marketing Start Date | 2019-09-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 78032cc1-d529-4d04-8a5c-22fe67ad5ded Details
INDICATIONS:
WARNINGS:
KEEP OUT OF REACH OF CHILDREN:
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:
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:
PACKAGE LABEL DISPLAY:
INGREDIENTS AND APPEARANCE
| SOMADERM
glandula suprarenalis suis, thyroidinum (bovine), hgh gel |
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| Labeler - Natural Life Foods Corporation dba XYGENYX (825154537) |
| Registrant - Apotheca Company (844330915) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Apotheca Company | 844330915 | manufacture(61877-0007) , api manufacture(61877-0007) , label(61877-0007) , pack(61877-0007) | |