SPL v1
SPL
SPL Set ID 2f6cb08e-64e2-cf05-e063-6294a90afc91
Route
EXTRACORPOREAL
Published
Effective Date 2025-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Emu Oil (1 g) Turmeric (0.8 g) Arnica Montana (0.5 g) Menthol (30 g)
Inactive Ingredients
Eucalyptus Oil Cinnamon Oil Glycerin Alcohol Aqua Isopropyl Alcohol

Identifiers & Packaging

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

Description

100g(3.53oz)


Medication Information

Warnings and Precautions

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

Indications and Usage

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 and Administration

100g(3.53oz)

Description

100g(3.53oz)

Section 50565-1

Keep out of reach of children

Section 51727-6

EUCALYPTUS OIL

CINNAMON OIL

GLYCERIN

ALCOHOL

ISOPROPYLAL COHOL

AQUA

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

EMU OIL

MENTHOL

ARNICA MONTANA

TURMERIC

Section 60561-8

Store in a clean, dry placeoulside of direct sunlight

Protect product fromexcessive moisture


Structured Label Content

Indications and Usage (34067-9)

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 and Administration (34068-7)

100g(3.53oz)

Warnings and Precautions (34071-1)

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

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

EUCALYPTUS OIL

CINNAMON OIL

GLYCERIN

ALCOHOL

ISOPROPYLAL COHOL

AQUA

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

EMU OIL

MENTHOL

ARNICA MONTANA

TURMERIC

Section 60561-8 (60561-8)

Store in a clean, dry placeoulside of direct sunlight

Protect product fromexcessive moisture


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)