Arthcal SOOTHING PAIN RELIEF MASSAGE

Products (1)

NDC Product Code

85212-0039

Application Number

ANDA075357

Marketing Category

ANDA (C73584)

Route of Administration

CUTANEOUS

Effective Date

May 14, 2025

Ingredients

emu oilActive

Code: 344821WD61Class: ACTIBQuantity: 1 g in 100 g

CINNAMON OILInactive

Code: E5GY4I6YCZClass: IACTQuantity: 0.5 g in 100 g

AQUAInactive

Code: 059QF0KO0RClass: IACTQuantity: 44.5 g in 100 g

GLYCERINInactive

Code: PDC6A3C0OXClass: IACTQuantity: 1 g in 100 g

EUCALYPTUS OILInactive

Code: 2R04ONI662Class: IACTQuantity: 0.8 g in 100 g

TurmericActive

Code: 856YO1Z64FClass: ACTIBQuantity: 1 g in 100 g

Arnica montanaActive

Code: O80TY208ZWClass: ACTIBQuantity: 2 g in 100 g

ISOPROPYL ALCOHOLInactive

Code: ND2M416302Class: IACTQuantity: 16.2 g in 100 g

MentholActive

Code: L7T10EIP3AClass: ACTIBQuantity: 3 g in 100 g

ALCOHOLInactive

Code: 3K9958V90MClass: IACTQuantity: 30 g in 100 g

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arthal Soothing Pain Relief MASSAGE GEL

INDICATIONS & USAGE SECTION

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

100g(3.53oz)

WARNINGS SECTION

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

OTC - ACTIVE INGREDIENT SECTION

EMU OIL
MENTHOL

ARNICA MONTANA

TURMERIC

OTC - PURPOSE SECTION

Topical Analgesic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

OTHER SAFETY INFORMATION

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

INACTIVE INGREDIENT SECTION

EUCALYPTUS OIL
CINNAMON OIL
GLYCERIN
ALCOHOL
ISOPROPYLAL COHOL
AQUA

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Arthcal SOOTHING PAIN RELIEF MASSAGE

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