SPL v1
SPL
SPL Set ID 44e1ec89-e2ea-d438-e063-6294a90a41f4
Route
TOPICAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Progesterone (16.9 mg)
Inactive Ingredients
Vanillyl Butyl Ether Menthol, Unspecified Form Pueraria Montana Var. Lobata Root Centella Asiatica Triterpenoids Purslane Polygonum Cuspidatum Root Polyglyceryl-3 Diisostearate Vitis Vinifera (grape) Seed Oil 1,2-hexanediol Cetyl Peg/ppg-10/1 Dimethicone (hlb 3.7) Butylene Glycol Glycerin Squalane Cimicifuga Racemosa Root Lavandula Angustifolia (lavender) Oil Peg-30 Dipolyhydroxystearate Soy Isoflavones Butyrospermum Parkii (shea) Butter Pueraria Mirifica Root Simmondsia Chinensis (jojoba) Seed Oil Magnesium Sulfate .alpha.-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-12-01

Description

Progesterone


Medication Information

Warnings and Precautions

Storage & Safety Instructions:As a precautionary measure,consultation with a physician is advisedprior to use for individuals who arepregnant, breastfeeding, planning apregnancy, taking any medication, orhave been diagnosed with a medicalcondition.For external use only. Not for oralconsumption. As with any product, incase of rash or irritation, discontinue use.Keep out of reach of children. Do not useif the safety seal is damaged or missing.Store in a cool, dry place.

Indications and Usage

Apply an appropriate amount of thisproduct to clean, dry, and thin skin areassuch as hands, feet, inner elbows, behindknees, or abdomen for optimal relief.Gently massage until absorbed. Ensurethat the product has been fullyabsorbed, wash hands after application,and avoid direct exposure to sunlight

Dosage and Administration

Apply one pump once or twice daily.To complement your skin's sensitivityduring your monthly rhythm, a pattern of3 weeks of use with a 1-week pause isrecommended (or as directed by a doctor)

Description

Progesterone

Section 50565-1

KEEP OUT OF REACH OF CHILDREN

Section 51727-6

WATER

BUTYLENE GLYCOL

GLYCERIN

TOCOPHERYL ACETATE

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

SQUALANE

VITIS VINIFERA (GRAPE) SEED OIL

MAGNESIUM SULFATE

POLYGLYCERYL-3 DIISOSTEARATE

CETYL PEG/PPG-10/1 DIMETHICONE

PEG-30 DIPOLYHYDROXYSTEARATE

1,2-HEXANEDIOL

SOY ISOFLAVONES

POLYGONUM CUSPIDATUM ROOT EXTRACT

PUERARIA LOBATA ROOT EXTRACT

VANILLYL BUTYL ETHER

BUTYROSPERMUM PARKII (SHEA BUTTER)

CENTELLA ASIATICA EXTRACT

PUERARIA MIRIFICA ROOT EXTRACT

MENTHOLUM

CIMICIFUGA RACEMOSA ROOT EXTRACT

PORTULACA OLERACEA EXTRACT

LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL

Section 51945-4

Section 55105-1

When applied to the skin, it may help with appearance

Section 55106-9

Progesterone


Structured Label Content

Indications and Usage (34067-9)

Apply an appropriate amount of thisproduct to clean, dry, and thin skin areassuch as hands, feet, inner elbows, behindknees, or abdomen for optimal relief.Gently massage until absorbed. Ensurethat the product has been fullyabsorbed, wash hands after application,and avoid direct exposure to sunlight

Dosage and Administration (34068-7)

Apply one pump once or twice daily.To complement your skin's sensitivityduring your monthly rhythm, a pattern of3 weeks of use with a 1-week pause isrecommended (or as directed by a doctor)

Warnings and Precautions (34071-1)

Storage & Safety Instructions:As a precautionary measure,consultation with a physician is advisedprior to use for individuals who arepregnant, breastfeeding, planning apregnancy, taking any medication, orhave been diagnosed with a medicalcondition.For external use only. Not for oralconsumption. As with any product, incase of rash or irritation, discontinue use.Keep out of reach of children. Do not useif the safety seal is damaged or missing.Store in a cool, dry place.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

WATER

BUTYLENE GLYCOL

GLYCERIN

TOCOPHERYL ACETATE

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

SQUALANE

VITIS VINIFERA (GRAPE) SEED OIL

MAGNESIUM SULFATE

POLYGLYCERYL-3 DIISOSTEARATE

CETYL PEG/PPG-10/1 DIMETHICONE

PEG-30 DIPOLYHYDROXYSTEARATE

1,2-HEXANEDIOL

SOY ISOFLAVONES

POLYGONUM CUSPIDATUM ROOT EXTRACT

PUERARIA LOBATA ROOT EXTRACT

VANILLYL BUTYL ETHER

BUTYROSPERMUM PARKII (SHEA BUTTER)

CENTELLA ASIATICA EXTRACT

PUERARIA MIRIFICA ROOT EXTRACT

MENTHOLUM

CIMICIFUGA RACEMOSA ROOT EXTRACT

PORTULACA OLERACEA EXTRACT

LAVANDULA ANGUSTIFOLIA (LAVENDER) OIL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

When applied to the skin, it may help with appearance

Section 55106-9 (55106-9)

Progesterone


Advanced Ingredient Data


Raw Label Data

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