FDA.reportPublic FDA data

P25 Progesterone 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 01:03:09

Label at a glance#

ProductP25 Progesterone Cream
Active ingredientPROGESTERONE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

DRUG FACTS

Active Ingredients

Micronizrd Progesterone USP (Wild Yam) 2.5%

OTC - PURPOSE SECTION

This is a topical cream that contains bio-identical progesterone 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 progesterone 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

WARNING: FOR EXTERNAL COSMETIC USE ONLY. Discontinue use if irritation or red skin develops, and consult a Physician. If pregnant, nursing, or if you have a serious medical condition consult a healthcare professional before using this product. Do not use with any other progesterone or progestins. Do not use if tamper-evident seal is broken or missing. California Prop 65 Law requires this statement: This product contains progesterone, a chemical known only to the State of California to cause cancer. Cease using this product and seek medical attention if skin irritation or other negative reactions occur. 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 Preservative) Radish Extract (Natural Preservative) Carbomer Allantoin Shea Butter Sunflower Lecithin Retinol (vitamin A) Sodium Bicarbonate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P25 Drug Facts LabelP25 Drug Facts Label

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82018-0011-52025-06-14C16284748780-1f386c649-f3da-0266-e053-dadaa90a7c1aP25 Progesterone Cream
82018-0011-52023-01-30C16284748780-1f386c649-f3da-0266-e053-dadaa90a7c1aP25 Progesterone Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82018-0011-5P25 Progesterone 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
82018-001182018-0011-5

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
OLIVE OIL6UYK2W1W1EIACT
COCONUT OILQ9L0O73W7LIACT
STEARIC ACID4ELV7Z65APIACT
PROGESTERONE4G7DS2Q64YACTIB
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
SHEA BUTTERK49155WL9YIACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM BICARBONATE8MDF5V39QOIACT

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
P25 Progesterone CreamPROGESTERONESHYNE BRANDSc47169b7-1b6a-2ad0-e053-2995a90a0b192025-06-01WarningsExact identifier
ndc (package): 82018-0011-5
ndc (product): 82018-0011
ndc11 (package): 82018001105
spl id: 3791c949-aa9f-0039-e063-6394a90a56ba
spl set id: c47169b7-1b6a-2ad0-e053-2995a90a0b19

Reported adverse events (FAERS/openFDA)#

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