BiEST 5.0 Estrogen 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 01:03:22
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
DRUG FACTS
Active Ingredients
Micronizrd Estriol USP (Wild Yam) .4%
Micronizrd Estradiol USP (Wild Yam) .1%
OTC - PURPOSE SECTION
This is a topical cream that contains bio-identical estriol and estradiol derived from wild yam and formulated in an 80:20 ratio. 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
USES:
This is a topical cream that contains bio-identical estriol and estradiol derived from wild yam and formulated in an 80:20 ratio. When applied to the skin it can help balance your hormones and provide temporary relief from menopausal symptoms such as hot flashes.
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.
WARNINGS SECTION
For external cosmetic use only. If pregnant or nursing, consult a healthcare professional before using this product. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement:
This product contains estrogen, a chemical known only to the state of California to cause cancer.
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, Vegetable Glycerin, Aloe Vera Gel,
Caprylic/Capric Triglyceride,Stearic Acid,Olive Oil,
Coconut Oil, Shea Butter, Sunflower Lecithin,
Methylsulfonylmethane (MSM), Stearyl Alcohol,
Isopropyl Palmitate,Allantoin,Carbomer,
Sodium Bicarbonate, Herbal-Active
(Natural Preservstive)
OTC - QUESTIONS SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ESTRADIOL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82018-0009-3 | 2025-06-17 | C162847 | 48780-1 | f386c64a-09ad-0266-e053-dadaa90a7c1a | BiEST 5.0 Estrogen Cream |
| 82018-0009-3 | 2023-01-30 | C162847 | 48780-1 | f386c64a-09ad-0266-e053-dadaa90a7c1a | BiEST 5.0 Estrogen Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82018-0009-3 | BiEST 5.0 Estrogen Cream | 85 g in 1 BOTTLE, PUMP | CREAM | 85 | 4 |
Products#
Every source-derived product name is available through these pages.
- BiEST 5.0 Estrogen Cream
- estriol,estradiol
- GLYCERIN
- ALLANTOIN
- LECITHIN, SUNFLOWER
- ESTRIOL
- ESTRADIOL
- ISOPROPYL PALMITATE
- STEARIC ACID
- SHEA BUTTER
- ALOE VERA LEAF
- COCONUT OIL
- SODIUM BICARBONATE
- OLIVE OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82018-0009 | 82018-0009-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| ALLANTOIN | 344S277G0Z | IACT |
| LECITHIN, SUNFLOWER | 834K0WOS5G | IACT |
| ESTRIOL | FB33469R8E | ACTIB |
| ESTRADIOL | 4TI98Z838E | ACTIB |
| ISOPROPYL PALMITATE | 8CRQ2TH63M | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| SHEA BUTTER | K49155WL9Y | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| OLIVE OIL | 6UYK2W1W1E | 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 |
|---|---|---|---|---|---|---|
| BiEST 5.0 Estrogen Cream | ESTRIOL,ESTRADIOL | SHYNE BRANDS | c4d3860f-c211-b18c-e053-2a95a90a4474 | 2025-06-01 | Warnings | 82018-0009-3 82018-0009 82018000903 37ca001c-de9a-f819-e063-6294a90a4c08 c4d3860f-c211-b18c-e053-2a95a90a4474 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
