SPL v1
SPL
SPL Set ID 43f84d44-18eb-7f88-e063-6394a90ab3d5
Route
TOPICAL
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1 g)
Inactive Ingredients
Hydrogenated Soybean Lecithin Xanthan Gum Dimethyl Sulfone Water Glycerin Dimethyl Sulfoxide Magnesium Chloride Stearic Acid Jojoba Oil Arginine Frankincense Curcumin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-10-13

Description

Arnica Montana Extract 1X HPUS 5% Zingiber officinale 3XHPUS 3%


Medication Information

Warnings and Precautions
  • For external use only.
Indications and Usage

Temporarily relieve discomfort caused by mild muscle and joint pain

Dosage and Administration

Apply a small amount of the product to the affected area 2-3 times daily.

Description

Arnica Montana Extract 1X HPUS 5% Zingiber officinale 3XHPUS 3%

Section 50565-1

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9
  • excessive irritation or rash develops, discontinue use.
  • condition persists for more than 3 days or worsens
  • symptoms clear up and occur again within a few days.
Section 50567-7
  • Avoid contact with eyes, mucous membranes. If contact occurs, rinse with water
  • Perform a patch test before first use.DMSO can transport other substances through the skin. Use only on clean, intact skin.
  • A mild warming, cooling sensation, or garlic-like odor(DMSO characteristic) is normal.
  • Do not use it if pregnant or breastfeeding.
  • Consult your healthcare provider before use, especially if you are taking medications or have a medical condition.
Section 50568-5

consult a physician before use if you are pregnant or nursing.

Section 50570-1
  • Do not apply to open wounds or broken skin.
  • You are allergic to Frankincense, Magnesium Chloride or other inactive ingredients in this product
Section 51727-6

Water

Glycerol

Dimethyl Sulfoxide

Dimethyl Sulfone

Magnesium Chloride

Stearic Acid

Jojoba Oil

Arginine

Curcumin

Frankincense Extract

Hydrogenated Lecithin

Vitamin E

Xanthan Gum

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Arnica Montana Extract 1X HPUS 5%

Zingiber officinale 3XHPUS 3%

Section 59845-8

Before use, Please wash your hands and clean the affected area with warm water.

Apply a small amount of the product to the affected area 2-3 times daily.

Gently massage until fully absorbed.

Section 60561-8
  • Do not use if glued carton end flaps are open or if the tube seal is broken.
  • Store at 68°-77°F (20°-25C).
  • Keep container tightly closed

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieve discomfort caused by mild muscle and joint pain

Dosage and Administration (34068-7)

Apply a small amount of the product to the affected area 2-3 times daily.

Warnings and Precautions (34071-1)
  • For external use only.
Section 50565-1 (50565-1)

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)
  • excessive irritation or rash develops, discontinue use.
  • condition persists for more than 3 days or worsens
  • symptoms clear up and occur again within a few days.
Section 50567-7 (50567-7)
  • Avoid contact with eyes, mucous membranes. If contact occurs, rinse with water
  • Perform a patch test before first use.DMSO can transport other substances through the skin. Use only on clean, intact skin.
  • A mild warming, cooling sensation, or garlic-like odor(DMSO characteristic) is normal.
  • Do not use it if pregnant or breastfeeding.
  • Consult your healthcare provider before use, especially if you are taking medications or have a medical condition.
Section 50568-5 (50568-5)

consult a physician before use if you are pregnant or nursing.

Section 50570-1 (50570-1)
  • Do not apply to open wounds or broken skin.
  • You are allergic to Frankincense, Magnesium Chloride or other inactive ingredients in this product
Section 51727-6 (51727-6)

Water

Glycerol

Dimethyl Sulfoxide

Dimethyl Sulfone

Magnesium Chloride

Stearic Acid

Jojoba Oil

Arginine

Curcumin

Frankincense Extract

Hydrogenated Lecithin

Vitamin E

Xanthan Gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Arnica Montana Extract 1X HPUS 5%

Zingiber officinale 3XHPUS 3%

Section 59845-8 (59845-8)

Before use, Please wash your hands and clean the affected area with warm water.

Apply a small amount of the product to the affected area 2-3 times daily.

Gently massage until fully absorbed.

Section 60561-8 (60561-8)
  • Do not use if glued carton end flaps are open or if the tube seal is broken.
  • Store at 68°-77°F (20°-25C).
  • Keep container tightly closed

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)