Arthcal ESTROGEN

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Beijing JUNGE Technology Co., Ltd.

DUNS Number

848718652

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Zhejiang Ayan Biotech Co., Ltd.

Labeler

Beijing JUNGE Technology Co., Ltd.

Registrant

Beijing JUNGE Technology Co., Ltd.

DUNS Number

544377996

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

85212-0038

Application Number

ANDA075357

Marketing Category

ANDA (C73584)

Route of Administration

CUTANEOUS

Effective Date

May 14, 2025

Ingredients

PUERARIA MIRIFICA ROOTInactive

Code: 892O4599HFClass: IACTQuantity: 0.5 mL in 100 mL

CIMICIFUGA RACEMOSA ROOTInactive

Code: K73E24S6X9Class: IACTQuantity: 0.1 mL in 100 mL

CARBOMERInactive

Code: 0A5MM307FCClass: IACTQuantity: 0.015 mL in 100 mL

POLYGONUM CUSPIDATUM ROOTInactive

Code: 7TRV45YZF7Class: IACTQuantity: 0.5 mL in 100 mL

CITRUS AURANTIUM DULCIS (ORANGE) PEEL OILInactive

Code: AKN3KSD11BClass: IACTQuantity: 0.015 mL in 100 mL

SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive

Code: 724GKU717MClass: IACTQuantity: 2 mL in 100 mL

EstriolActive

Code: FB33469R8EClass: ACTIBQuantity: 0.2 g in 100 mL

PANAX GINSENG ROOTInactive

Code: CUQ3A77YXIClass: IACTQuantity: 0.1 mL in 100 mL

AVENA SATIVA (OAT) BRANInactive

Code: KQX236OK4UClass: IACTQuantity: 0.1 mL in 100 mL

ARGININEInactive

Code: 94ZLA3W45FClass: IACTQuantity: 0.015 mL in 100 mL

1,2-HEXANEDIOLInactive

Code: TR046Y3K1GClass: IACTQuantity: 0.015 mL in 100 mL

CETEARYL ALCOHOLInactive

Code: 2DMT128M1SClass: IACTQuantity: 1 mL in 100 mL

SQUALANEInactive

Code: GW89575KF9Class: IACTQuantity: 2 mL in 100 mL

BUTYROSPERMUM PARKII (SHEA) OILInactive

Code: O88E196QRFClass: IACTQuantity: 2 mL in 100 mL

BUTYLENE GLYCOLInactive

Code: 3XUS85K0RAClass: IACTQuantity: 5 mL in 100 mL

GLYCERINInactive

Code: PDC6A3C0OXClass: IACTQuantity: 5 mL in 100 mL

ALOE BARBADENSIS LEAF JUICEInactive

Code: RUE8E6T4NBClass: IACTQuantity: 0.5 mL in 100 mL

COCOS NUCIFERA (COCONUT) OILInactive

Code: Q9L0O73W7LClass: IACTQuantity: 5 mL in 100 mL

SOY ISOFLAVONESInactive

Code: 71B37NR06DClass: IACTQuantity: 0.5 mL in 100 mL

PUNICA GRANATUM FRUIT JUICEInactive

Code: 99S671U9KBClass: IACTQuantity: 0.1 mL in 100 mL

AQUAInactive

Code: 059QF0KO0RClass: IACTQuantity: 73.61 mL in 100 mL

TOCOPHEROLInactive

Code: R0ZB2556P8Class: IACTQuantity: 1 mL in 100 mL

CAMELLIA SINENSIS LEAFInactive

Code: W2ZU1RY8B0Class: IACTQuantity: 0.1 mL in 100 mL

CAPRYLYL GLYCOLInactive

Code: 00YIU5438UClass: IACTQuantity: 0.015 mL in 100 mL

TRIFOLIUM PRATENSE (CLOVER) FLOWERInactive

Code: 4JS0838828Class: IACTQuantity: 0.1 mL in 100 mL

HYALURONIC ACIDInactive

Code: S270N0TRQYClass: IACTQuantity: 0.015 mL in 100 mL

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arthcal ESTROGEN CREAM

INDICATIONS & USAGE SECTION

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 & ADMINISTRATION SECTION

50G/1.76OZ

WARNINGS SECTION

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

PRECAUTIONS SECTION

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 alergicreaction occurs, discontinue useimmediately and consult a doctor.

6. Keep Out of Reach of Children.

OTC - ACTIVE INGREDIENT SECTION

BUTYROSPERMUM PARKII (SHEA BUTTER)
TOCOPHEROL
Estriol

OTC - PURPOSE SECTION

Reduce Hot Flashes
Menopause Relief
Menstrual Cycle Support
Hormone Balance

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INSTRUCTIONS FOR USE SECTION

Women in menopause or perimenopause.
Those with aging skin seeking a medical-grade solution.

Anyone with hormonal imbalance-related skin concerns.

INACTIVE INGREDIENT SECTION

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

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Arthcal ESTROGEN

FDA Approval Summary

Registrants1

Manufacturing Establishments1

Products1