SPL v1
SPL
SPL Set ID 2f2f71c2-763d-0290-e063-6394a90a72ca
Route
EXTRACORPOREAL
Published
Effective Date 2025-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tocopherol (0.1 g) Butyrospermum Parkii (shea) Butter (74.21 g) Estriol (5 g)
Inactive Ingredients
Cimicifuga Racemosa Root Punica Granatum Whole Aqua Butylene Glycol Glycerin Cetearyl Alcohol Pueraria Mirifica Root Simmondsia Chinensis (jojoba) Seed Oil Panax Ginseng Root Trifolium Pratense (clover) Flower Camellia Sinensis Leaf Oil Arginine Caprylyl Glycol Citrus Aurantium Dulcis (orange) Peel Oil Hyaluronic Acid Aloe Barbadensis Leaf Juice Soy Isoflavones Carbomer 1,2-hexanediol Cocos Nucifera (coconut) Oil Polygonum Cuspidatum Root Squalane

Identifiers & Packaging

Pill Appearance
Shape: freeform
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-10

Description

50G/1.76OZ


Medication Information

Warnings and Precautions

For external use only. Keep out of reach of children.Avoid contact with eyes.

Indications and Usage

Apply to clean skin (face, neck, or body) twice daily.

For optimal results, combine with a daily skincare routine.

Consult your healthcare provider before use if you have specific medical concerns.

Dosage and Administration

50G/1.76OZ

Description

50G/1.76OZ

Section 42232-9





1. For Extemal Use Only. 2. Avoid Direct Contact with Eyes. 3. If the product

gets into your eyes, rinse immediately with plenty of water. 4. Ensure skin is

not broken or severely irritated before use. 5. If any discomfort dor alergic

reaction occurs, discontinue useimmediately and consult a doctor. 6. Keep

Out of Reach of Children.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

AQUA

BUTYLENE GLYCOL

GLYCERIN

COCOS NUCIFERA (COCONUT) OIL

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

SQUALANE

CETEARYL ALCOHOL

ALOE BARBADENSIS LEAF JUICE

SOY ISOFLAVONES

POLYGONUM CUSPIDATUM ROOT EXTRACT

PUERARIA MIRIFICA ROOT EXTRACT

CIMICIFUGA RACEMOSA ROOT EXTRACT

PUNICA GRANATUM FRUIT EXTRACT

TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT

CAMELLIA SINENSIS LEAF EXTRACT

PANAX GINSENG ROOT EXTRACT

CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL

HYALURONIC ACID

CARBOMER

ARGININE

1,2-HEXANEDIOL

CAPRYLYL GLYCOL

Section 51945-4

Section 55105-1

Reduce Hot Flashes

Menopause Relief

Menstrual Cycle Support

Hormone Balance

Section 55106-9

BUTYROSPERMUM PARKII (SHEA BUTTER)

TOCOPHEROL

Estriol

Section 59845-8

Women in menopause or perimenopause.

Those with aging skin seeking a medical-grade solution.

Anyone with hormonal imbalance-related skin concerns.


Structured Label Content

Indications and Usage (34067-9)

Apply to clean skin (face, neck, or body) twice daily.

For optimal results, combine with a daily skincare routine.

Consult your healthcare provider before use if you have specific medical concerns.

Dosage and Administration (34068-7)

50G/1.76OZ

Warnings and Precautions (34071-1)

For external use only. Keep out of reach of children.Avoid contact with eyes.

Section 42232-9 (42232-9)





1. For Extemal Use Only. 2. Avoid Direct Contact with Eyes. 3. If the product

gets into your eyes, rinse immediately with plenty of water. 4. Ensure skin is

not broken or severely irritated before use. 5. If any discomfort dor alergic

reaction occurs, discontinue useimmediately and consult a doctor. 6. Keep

Out of Reach of Children.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

AQUA

BUTYLENE GLYCOL

GLYCERIN

COCOS NUCIFERA (COCONUT) OIL

SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL

SQUALANE

CETEARYL ALCOHOL

ALOE BARBADENSIS LEAF JUICE

SOY ISOFLAVONES

POLYGONUM CUSPIDATUM ROOT EXTRACT

PUERARIA MIRIFICA ROOT EXTRACT

CIMICIFUGA RACEMOSA ROOT EXTRACT

PUNICA GRANATUM FRUIT EXTRACT

TRIFOLIUM PRATENSE (CLOVER) FLOWER EXTRACT

CAMELLIA SINENSIS LEAF EXTRACT

PANAX GINSENG ROOT EXTRACT

CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL

HYALURONIC ACID

CARBOMER

ARGININE

1,2-HEXANEDIOL

CAPRYLYL GLYCOL

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Reduce Hot Flashes

Menopause Relief

Menstrual Cycle Support

Hormone Balance

Section 55106-9 (55106-9)

BUTYROSPERMUM PARKII (SHEA BUTTER)

TOCOPHEROL

Estriol

Section 59845-8 (59845-8)

Women in menopause or perimenopause.

Those with aging skin seeking a medical-grade solution.

Anyone with hormonal imbalance-related skin concerns.


Advanced Ingredient Data


Raw Label Data

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