FDA.reportPublic FDA data

BiEST 2.5 Estrogen Cream

Manufacturer
SHYNE BRANDS
Effective date
2021-06-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:40:57

Label at a glance#

ProductBiEST 2.5 Estrogen Cream
Active ingredientESTRIOL, ESTRADIOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

Active Ingredients

Micronizrd Estriol USP (Wild Yam) .2%

Micronizrd Estradiol USP (Wild Yam) .05%

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

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.

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, Glycerin (Plant Source-Kosher), Aloe Vera
Gel,Caprylic/Capric Triglyceride,Stearic Acid, MSM
(Methylsulfonylmethane), Olive Oil, Coconut Oil, Isopropyl
Palmitate, Stearyl Alcohol, Vitamin E, Herbal-Active
(Natural Preservstive), Radish Extract (Natural
Preservative), Carbomer, Allantoin, Shea Butter, Sunflower
Lecithin, Sodium Bicarbonate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BiEST 2.5 LabelBiEST 2.5 Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ESTRADIOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82018-0007-12023-01-30C16284748780-1f386c649-ba90-0266-e053-dadaa90a7c1aBiEST 2.5 Estrogen Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82018-0007-1BiEST 2.5 Estrogen Cream85 g in 1 BOTTLE, PUMPCREAM853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82018-0007BIEST 2.5 ESTROGEN CREAM (ESTRIOL,ESTRADIOL) CREAM [SHYNE BRANDS]3Legacy NDC, 1 package rows20210622_c4d3860f-c20f-b18c-e053-2a95a90a4474.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82018-000782018-0007-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARIC ACID4ELV7Z65APIACT
ALLANTOIN344S277G0ZIACT
COCONUT OILQ9L0O73W7LIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ESTRIOLFB33469R8EACTIB
ESTRADIOL4TI98Z838EACTIB
OLIVE OIL6UYK2W1W1EIACT
SHEA BUTTERK49155WL9YIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c54e2401-6293-365e-e053-2995a90a09bfc4d3860f-c20f-b18c-e053-2a95a90a44742021-06-21WarningsExact identifier
spl id: c54e2401-6293-365e-e053-2995a90a09bf
spl set id: c4d3860f-c20f-b18c-e053-2a95a90a4474

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.