FDA.reportPublic FDA data

Advanced Formula Estro-Life

Manufacturer
Smoky Mountain Naturals, LLC - DBA SMNutrition
Effective date
2022-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:04:38

Label at a glance#

ProductAdvanced Formula Estro-Life
Active ingredientESTRIOL
Label structure7 sections

Indications and uses

This is a topical cream that contains micronized, USP estriol. When applied to the skin it may help support the body’s balance of hormones. 

Dosage and administration

Apply 1/4 tsp to thin skin, inner wrist, or abdomen daily or as recommended by your physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Estriol

Purpose

OTC - PURPOSE SECTION

This is a topical cream that contains micronized, USP estriol. When applied to the skin it may help support the body’s balance of hormones.

Uses

INDICATIONS & USAGE SECTION

This is a topical cream that contains micronized, USP estriol. When applied to the skin it may help support the body’s balance of hormones. 

Warnings

WARNINGS SECTION

*These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. Consult your healthcare provider before using this product especially if you are pregnant, nursing, intend to get pregnant, taking medication, or have a medical condition. This product does not treat, cure, or prevent menopause. If irritation occurs, discontinue use. For external use only. Do not use around eye area. Do not apply this cream internally. Double check the ingredients list for known allergies before using this cream.

Keep out of the reach of children. Do not use if safety seal is missing or broken. Store in a cool, dry place.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply 1/4 tsp to thin skin, inner wrist, or abdomen daily or as recommended by your physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Deionized Water, Propylene Glycol, Sorbitol, Glyceryl Stearate, Stearic Acid, Dimethicone, Steareth-2, Steareth-20, Retinyl Palmitate, Tocopheryl Acetate, Methylparaben, Propylparaben.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82653-002-012025-12-23C16284748780-11030e365-604b-111a-e063-dadaa90a10e2887943d7-9dec-4352-aac0-e8006edc63ea
82653-002-022025-12-23C16284748780-11030e365-604b-111a-e063-dadaa90a10e2887943d7-9dec-4352-aac0-e8006edc63ea
82653-002-012024-01-30C16284748780-11030e365-604b-111a-e063-dadaa90a10e2887943d7-9dec-4352-aac0-e8006edc63ea
82653-002-022024-01-30C16284748780-11030e365-604b-111a-e063-dadaa90a10e2887943d7-9dec-4352-aac0-e8006edc63ea

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82653-002ADVANCED FORMULA ESTRO-LIFE (ESTRIOL) CREAM [SMOKY MOUNTAIN NATURALS, LLC - DBA SMNUTRITION]1Legacy NDC20220401_887943d7-9dec-4352-aac0-e8006edc63ea.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82653-00282653-002-01, 82653-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARIC ACID4ELV7Z65APIACT
DIMETHICONE92RU3N3Y1OIACT
STEARETH-2V56DFE46J5IACT
STEARETH-20L0Q8IK9E08IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM HYDROXYMETHYLGLYCINATEDIG6BWZ9XTIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
ESTRIOLFB33469R8EACTIB

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
46a303d0-14c7-775c-e063-6394a90a6ff3887943d7-9dec-4352-aac0-e8006edc63ea2025-12-23WarningsExact identifier
spl set id: 887943d7-9dec-4352-aac0-e8006edc63ea

Reported adverse events (FAERS/openFDA)#

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