SPL v1
SPL
SPL Set ID 1d993fe0-2c46-426c-8922-388723e744f4
Route
TOPICAL
Published
Effective Date 2025-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (5 g)
Inactive Ingredients
Aloe Vera Flower Alcohol Egmol Shea Butter Caprylyl Caprylate/caprate Cetostearyl Alcohol Polyoxyl 20 Cetostearyl Ether Turmerone, Ar-(+/-)- Dehydroacetic Acid Glycerin Glyceryl Monostearate Soybean Oil Magnesium Chloride Menthyl Ethylene Glycol Carbonate, (-)- Isopropyl Myristate Propanediol Jojoba Oil Tocopherol Dimethyl Sulfone Lavender Oil Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-02-15

Description

Active Ingredients      Purpose Arnica Montana Extract 1X HPUS (5%)                                                         Anti-inflammatory


Medication Information

Description

Active Ingredients      Purpose Arnica Montana Extract 1X HPUS (5%)                                                         Anti-inflammatory

Uses
  • Temporarily relieves muscle pain, swelling and inflammation.
Section 50565-1

Section 55105-1

Section 55106-9

Active Ingredients      Purpose

Arnica Montana Extract

1X HPUS (5%)                                                         Anti-inflammatory

Warnings

For external use only

  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly. Avoid contact with eyes.
  • If conditions worsen or persist for more than 7 days, discontinue use of this product and consult a physician.

Ask a doctor before use:

  • If pregnant or breast feeding
  • Children under 2 years of age

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

Directions
  • Rub directly on tight and tense muscles including legs, feet, neck, shoulders, arms, hands, etc.
  • Avoid applying to sensitive areas.
  • Apply to affected area not more than 3 to 4 times daily.
Product Label

Other Information

Store at room temperature.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Alcohol, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Caprylyl Caprylate/Caprate,Cetearyl Alcohol, Ceteareth-20, Curcuma Longa (Turmeric) Root Extract, Dehydroacetic Acid, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Lavendar Oil , Magnesium Chloride, Menthyl Lactate, Isopropyl Myristate, Sea Water Extract, Propanediol,Simmondisia Chinensis (Jojoba Seed Oil), Tocopherol, Water


Structured Label Content

Uses
  • Temporarily relieves muscle pain, swelling and inflammation.
Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Section 55106-9 (55106-9)

Active Ingredients      Purpose

Arnica Montana Extract

1X HPUS (5%)                                                         Anti-inflammatory

Warnings

For external use only

  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly. Avoid contact with eyes.
  • If conditions worsen or persist for more than 7 days, discontinue use of this product and consult a physician.

Ask a doctor before use:

  • If pregnant or breast feeding
  • Children under 2 years of age

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

Directions
  • Rub directly on tight and tense muscles including legs, feet, neck, shoulders, arms, hands, etc.
  • Avoid applying to sensitive areas.
  • Apply to affected area not more than 3 to 4 times daily.
Product Label (Product label)

Other Information

Store at room temperature.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Alcohol, Benzyl Alcohol, Butyrospermum Parkii (Shea) Butter, Caprylyl Caprylate/Caprate,Cetearyl Alcohol, Ceteareth-20, Curcuma Longa (Turmeric) Root Extract, Dehydroacetic Acid, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Lavendar Oil , Magnesium Chloride, Menthyl Lactate, Isopropyl Myristate, Sea Water Extract, Propanediol,Simmondisia Chinensis (Jojoba Seed Oil), Tocopherol, Water


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)