Websitewww.biolabspro.com
www.biolabspro.com
www.biolabspro.comP50 Progesterone Cream
- Manufacturer
- SHYNE BRANDS
- Effective date
- 2025-06-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 01:03:09
Label at a glance#
ProductP50 Progesterone Cream
Active ingredientPROGESTERONE
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
DRUG FACTS
Active Ingredients
Micronizrd Progesterone USP (Wild Yam) 5%
OTC - PURPOSE SECTION
This is a topical cream that contains bio-identical progesterone derived from wild yam. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes.
INDICATIONS & USAGE SECTION
DIRECTIONS: Apply once or twice a day. Massage into inner arms, thighs, chest or apply to inner forearm and rub arms together or use as directed by your Physician.
THIS CONTAINER Yields approximately 70 full pumps or 50 mg of bio-identical Progesterone USP (5%) per pump. This is an All Natural product. Application is intended for external cosmetic use.
WARNINGS SECTION
WARNING: FOR EXTERNAL COSMETIC USE ONLY. Discontinue use if irritation or red skin develops, and consult a Physician. If pregnant, nursing, or if you have a serious medical condition consult a healthcare professional before using this product. Do not use with any other progesterone or progestins. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement: This product contains progesterone, a chemical known only to the State of California to cause cancer. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. KEEP OUT OF REACH OF CHILDREN.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or nursing or if you have a serious medical condition consult a healthcare professional before using this product.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep Out of Reach of Children.
DOSAGE & ADMINISTRATION SECTION
Apply once or twice a day. Massage into inner arms, thighs, chest or apply to inner forearm and rub arms together or use as directed by you physician.
INACTIVE INGREDIENT SECTION
Purified Water, Glycerin (Plant source - kosher) Aloe Vera Gel, Caprylic/Capric Triglyceride, Stearic Acid, MSM (Methylsulfonylmethane), Olive Oil, Coconut Oil, Isopropyl Palmitate, Stearyl Alcohol, Vitamin E, Blend of Essential oils and herbs (Natural Preservative), Radish Extract (Natural Preservative) Carbomer Allantoin Shea Butter Sunflower Lecithin Sodium Bicarbonate.
OTC - QUESTIONS SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| PROGESTERONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b46148e2-ee15-98d5-12f0-f5ec8745f6fc | Product name | 3 | 20220927 |
| 76820076-f087-4073-b1d1-aa04b361335e | Product name | 2 | 20220921 |
| d3229c1a-4e51-4e04-9b13-00d24fd35242 | Product name | 1 | 20200821 |
| 213f0591-95c1-b398-40b7-08b31f66b026 | Product name | 4 | 20190206 |
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
| 85b2d644-53b2-f2dc-4dbc-859116ce56c0 | Product name | 1 | 20140508 |
| d048f0e3-3c40-8816-8c5c-0ca5cd189aac | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82018-0012-6 | 2025-06-14 | C162847 | 48780-1 | f386c649-dbe6-0266-e053-dadaa90a7c1a | P50 Progesterone Cream |
| 82018-0012-6 | 2023-01-30 | C162847 | 48780-1 | f386c649-dbe6-0266-e053-dadaa90a7c1a | P50 Progesterone Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82018-0012-6 | P50 Progesterone Cream | 85000 mg in 1 BOTTLE, PUMP | CREAM | 85000 | 4 |
Products#
Every source-derived product name is available through these pages.
- P50 Progesterone Cream
- Progesterone
- ALLANTOIN
- GLYCERIN
- ISOPROPYL PALMITATE
- STEARIC ACID
- LECITHIN, SUNFLOWER
- SHEA BUTTER
- ALOE VERA LEAF
- OLIVE OIL
- COCONUT OIL
- SODIUM BICARBONATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82018-0012 | 82018-0012-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALLANTOIN | 344S277G0Z | IACT |
| PROGESTERONE | 4G7DS2Q64Y | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| ISOPROPYL PALMITATE | 8CRQ2TH63M | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| LECITHIN, SUNFLOWER | 834K0WOS5G | IACT |
| SHEA BUTTER | K49155WL9Y | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| OLIVE OIL | 6UYK2W1W1E | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| P50 Progesterone Cream | PROGESTERONE | SHYNE BRANDS | c47121df-6c04-b273-e053-2a95a90aa549 | 2025-06-01 | Warnings | 82018-0012-6 82018-0012 82018001206 3792493b-80b7-2a3e-e063-6394a90aed7c c47121df-6c04-b273-e053-2a95a90aa549 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.