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Arthcal ESTROGEN

Approved
Approval ID

3515b12e-5c2e-2e7c-e063-6394a90aa636

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 14, 2025

Manufacturers
FDA

Beijing JUNGE Technology Co., Ltd.

DUNS: 848718652

Products 1

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

ESTROGEN

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85212-0038
Application NumberANDA075357
Product Classification
M
Marketing Category
C73584
G
Generic Name
ESTROGEN
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateMay 14, 2025
FDA Product Classification

INGREDIENTS (26)

PUERARIA MIRIFICA ROOTInactive
Quantity: 0.5 mL in 100 mL
Code: 892O4599HF
Classification: IACT
CIMICIFUGA RACEMOSA ROOTInactive
Quantity: 0.1 mL in 100 mL
Code: K73E24S6X9
Classification: IACT
CARBOMERInactive
Quantity: 0.015 mL in 100 mL
Code: 0A5MM307FC
Classification: IACT
POLYGONUM CUSPIDATUM ROOTInactive
Quantity: 0.5 mL in 100 mL
Code: 7TRV45YZF7
Classification: IACT
CITRUS AURANTIUM DULCIS (ORANGE) PEEL OILInactive
Quantity: 0.015 mL in 100 mL
Code: AKN3KSD11B
Classification: IACT
SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive
Quantity: 2 mL in 100 mL
Code: 724GKU717M
Classification: IACT
ESTRIOLActive
Quantity: 0.2 g in 100 mL
Code: FB33469R8E
Classification: ACTIB
PANAX GINSENG ROOTInactive
Quantity: 0.1 mL in 100 mL
Code: CUQ3A77YXI
Classification: IACT
AVENA SATIVA (OAT) BRANInactive
Quantity: 0.1 mL in 100 mL
Code: KQX236OK4U
Classification: IACT
ARGININEInactive
Quantity: 0.015 mL in 100 mL
Code: 94ZLA3W45F
Classification: IACT
1,2-HEXANEDIOLInactive
Quantity: 0.015 mL in 100 mL
Code: TR046Y3K1G
Classification: IACT
CETEARYL ALCOHOLInactive
Quantity: 1 mL in 100 mL
Code: 2DMT128M1S
Classification: IACT
SQUALANEInactive
Quantity: 2 mL in 100 mL
Code: GW89575KF9
Classification: IACT
BUTYROSPERMUM PARKII (SHEA) OILInactive
Quantity: 2 mL in 100 mL
Code: O88E196QRF
Classification: IACT
BUTYLENE GLYCOLInactive
Quantity: 5 mL in 100 mL
Code: 3XUS85K0RA
Classification: IACT
GLYCERINInactive
Quantity: 5 mL in 100 mL
Code: PDC6A3C0OX
Classification: IACT
ALOE BARBADENSIS LEAF JUICEInactive
Quantity: 0.5 mL in 100 mL
Code: RUE8E6T4NB
Classification: IACT
COCOS NUCIFERA (COCONUT) OILInactive
Quantity: 5 mL in 100 mL
Code: Q9L0O73W7L
Classification: IACT
SOY ISOFLAVONESInactive
Quantity: 0.5 mL in 100 mL
Code: 71B37NR06D
Classification: IACT
PUNICA GRANATUM FRUIT JUICEInactive
Quantity: 0.1 mL in 100 mL
Code: 99S671U9KB
Classification: IACT
AQUAInactive
Quantity: 73.61 mL in 100 mL
Code: 059QF0KO0R
Classification: IACT
TOCOPHEROLInactive
Quantity: 1 mL in 100 mL
Code: R0ZB2556P8
Classification: IACT
CAMELLIA SINENSIS LEAFInactive
Quantity: 0.1 mL in 100 mL
Code: W2ZU1RY8B0
Classification: IACT
CAPRYLYL GLYCOLInactive
Quantity: 0.015 mL in 100 mL
Code: 00YIU5438U
Classification: IACT
TRIFOLIUM PRATENSE (CLOVER) FLOWERInactive
Quantity: 0.1 mL in 100 mL
Code: 4JS0838828
Classification: IACT
HYALURONIC ACIDInactive
Quantity: 0.015 mL in 100 mL
Code: S270N0TRQY
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/1/2025

Arthcal ESTROGEN CREAM

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2025

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

LOINC: 34068-7Updated: 1/1/2025

50G/1.76OZ

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 1/1/2025

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.

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 1/1/2025

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

Anyone with hormonal imbalance-related skin concerns.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 1/1/2025

BUTYROSPERMUM PARKII (SHEA BUTTER)
TOCOPHEROL
Estriol

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/1/2025

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

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2025

Reduce Hot Flashes
Menopause Relief
Menstrual Cycle Support
Hormone Balance

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2025

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

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2025

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

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Arthcal ESTROGEN - FDA Drug Approval Details