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#

ProductEstriol 5.0 Cream
Active ingredientESTRIOL
Label structure10 sections

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Estriol LabelEstriol Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82018-0010-42025-06-17C16284748780-1f386c64a-3a13-0266-e053-dadaa90a7c1aEstriol 5.0 Cream
82018-0010-42023-01-30C16284748780-1f386c64a-3a13-0266-e053-dadaa90a7c1aEstriol 5.0 Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82018-0010-4Estriol 5.0 Cream85 g in 1 BOTTLE, PUMPCREAM854

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82018-001082018-0010-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
Estriol 5.0 CreamESTRIOLSHYNE BRANDSc4d3d276-f78e-17c1-e053-2995a90a590d2025-06-01WarningsExact identifier
ndc (package): 82018-0010-4
ndc (product): 82018-0010
ndc11 (package): 82018001004
spl id: 37c9f33a-9823-ec65-e063-6294a90a6773
spl set id: c4d3d276-f78e-17c1-e053-2995a90a590d

Reported adverse events (FAERS/openFDA)#

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