Estriol 5.0 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) .5%
OTC - PURPOSE SECTION
This is a topical cream that contains bio-identical estriol 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
USES:
This is a topical cream that contains bio-identical estriol 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.
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 Preservative)
OTC - QUESTIONS SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ebc62596-fc97-4d03-9483-7ba095d25db7 | Product name | 1 | 20151210 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82018-0010-4 | 2025-06-17 | C162847 | 48780-1 | f386c64a-3a13-0266-e053-dadaa90a7c1a | Estriol 5.0 Cream |
| 82018-0010-4 | 2023-01-30 | C162847 | 48780-1 | f386c64a-3a13-0266-e053-dadaa90a7c1a | Estriol 5.0 Cream |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82018-0010-4 | Estriol 5.0 Cream | 85 g in 1 BOTTLE, PUMP | CREAM | 85 | 4 |
Products#
Every source-derived product name is available through these pages.
- Estriol 5.0 Cream
- estriol
- STEARIC ACID
- ALLANTOIN
- LECITHIN, SUNFLOWER
- SHEA BUTTER
- COCONUT OIL
- ALOE VERA LEAF
- OLIVE OIL
- SODIUM BICARBONATE
- ISOPROPYL PALMITATE
- GLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 82018-0010 | 82018-0010-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| STEARIC ACID | 4ELV7Z65AP | IACT |
| ALLANTOIN | 344S277G0Z | IACT |
| LECITHIN, SUNFLOWER | 834K0WOS5G | IACT |
| SHEA BUTTER | K49155WL9Y | IACT |
| COCONUT OIL | Q9L0O73W7L | IACT |
| ALOE VERA LEAF | ZY81Z83H0X | IACT |
| OLIVE OIL | 6UYK2W1W1E | IACT |
| SODIUM BICARBONATE | 8MDF5V39QO | IACT |
| ISOPROPYL PALMITATE | 8CRQ2TH63M | IACT |
| ESTRIOL | FB33469R8E | ACTIB |
| GLYCERIN | PDC6A3C0OX | 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 |
|---|---|---|---|---|---|---|
| Estriol 5.0 Cream | ESTRIOL | SHYNE BRANDS | c4d3d276-f78e-17c1-e053-2995a90a590d | 2025-06-01 | Warnings | 82018-0010-4 82018-0010 82018001004 37c9f33a-9823-ec65-e063-6294a90a6773 c4d3d276-f78e-17c1-e053-2995a90a590d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
