MedPath

Arthcal SOOTHING PAIN RELIEF MASSAGE

Approved
Approval ID

3524ad62-0ed6-f2e5-e063-6394a90a3283

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.

SOOTHING PAIN RELIEF MASSAGE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85212-0039
Application NumberANDA075357
Product Classification
M
Marketing Category
C73584
G
Generic Name
SOOTHING PAIN RELIEF MASSAGE
Product Specifications
Route of AdministrationCUTANEOUS
Effective DateMay 14, 2025
FDA Product Classification

INGREDIENTS (10)

EMU OILActive
Quantity: 1 g in 100 g
Code: 344821WD61
Classification: ACTIB
CINNAMON OILInactive
Quantity: 0.5 g in 100 g
Code: E5GY4I6YCZ
Classification: IACT
AQUAInactive
Quantity: 44.5 g in 100 g
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Quantity: 1 g in 100 g
Code: PDC6A3C0OX
Classification: IACT
EUCALYPTUS OILInactive
Quantity: 0.8 g in 100 g
Code: 2R04ONI662
Classification: IACT
TURMERICActive
Quantity: 1 g in 100 g
Code: 856YO1Z64F
Classification: ACTIB
ARNICA MONTANAActive
Quantity: 2 g in 100 g
Code: O80TY208ZW
Classification: ACTIB
ISOPROPYL ALCOHOLInactive
Quantity: 16.2 g in 100 g
Code: ND2M416302
Classification: IACT
MENTHOLActive
Quantity: 3 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB
ALCOHOLInactive
Quantity: 30 g in 100 g
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Arthal Soothing Pain Relief MASSAGE GEL

INDICATIONS & USAGE SECTION

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

Wash and dry the area to be applied.
Massage gently until absorbed into the skin.
Adult dosage: apply to affected area not more than 3 to 4 times daily.
For children under 14 years of age: Consult a doct

DOSAGE & ADMINISTRATION SECTION

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

100g(3.53oz)

OTC - ACTIVE INGREDIENT SECTION

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

EMU OIL
MENTHOL

ARNICA MONTANA

TURMERIC

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Keep out of reach of children

INACTIVE INGREDIENT SECTION

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

EUCALYPTUS OIL
CINNAMON OIL
GLYCERIN
ALCOHOL
ISOPROPYLAL COHOL
AQUA

OTC - PURPOSE SECTION

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

Topical Analgesic

WARNINGS SECTION

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

For external use only
Do not apply to wounds or damaged skin
Do not bandage tightly .Avoid contact with eyes
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center immediately.
lf condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within afew days, discontinue use of this product and consult a physician
lf pregnant or breast feeding, ask a health professional before use

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 1/1/2025

Store in a clean, dry placeoulside of direct sunlight
Protect product fromexcessive moisture

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Arthcal SOOTHING PAIN RELIEF MASSAGE - FDA Drug Approval Details