SPL v2
SPL
SPL Set ID 0174092f-e10f-4c93-a677-facbdcf1a6ea
Route
TOPICAL
Published
Effective Date 2025-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (7 mg)
Inactive Ingredients
Water Shea Butter Tocopherol Tetrahexyldecyl Ascorbate Allantoin Aloe Barbadensis Leaf Juice Calendula Officinalis Flower Centella Asiatica Triterpenoids Purslane Coconut Oil Phytonadione Escin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-07-19

Description

Active ingredient: Arnica Montana 1X HPUS (7%)


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses: Temporarily relieves pain, swelling, and discoloration associated with:

  • Bruises
  • Minor falls
  • Sports injuries
  • Muscle soreness
Dosage and Administration

Directions:

  • Apply a thin layer to the affected area 2 to 3 times daily.
  • Gently massage until absorbed.
  • Use as soon as possible after minor injury.
Description

Active ingredient: Arnica Montana 1X HPUS (7%)

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
Section 50567-7

When using this product

Avoid contact with eyes.

Section 50570-1

Do not apply to broken skin or open wounds. Avoid contact with eyes.

Section 51727-6

Inactive ingredients:

  • Purified Water
  • Butyrospermum Parkii (Shea Butter)
  • Tocopherol (Vitamin E)
  • Tetrahexyldecyl Ascorbate (Vitamin C)
  • Allantoin
  • Aloe Barbadensis Leaf Juice
  • Calendula Officinalis Flower Extract
  • Centella Asiatica Extract
  • Portulaca Oleracea Extract
  • Cocos Nucifera (Coconut) Oil
  • Phytonadione (Vitamin K)
  • Escin
Section 53413-1

Questions or comments?

Contact us at [email protected]

Section 53414-9

If pregnant or breast-feeding

Ask a health professional before use

Section 55105-1

Purpuse:Bruise Relief.

"HPUS" indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 55106-9

Active ingredient:

  • Arnica Montana 1X HPUS (7%)
Package Label.principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Uses: Temporarily relieves pain, swelling, and discoloration associated with:

  • Bruises
  • Minor falls
  • Sports injuries
  • Muscle soreness
Dosage and Administration (34068-7)

Directions:

  • Apply a thin layer to the affected area 2 to 3 times daily.
  • Gently massage until absorbed.
  • Use as soon as possible after minor injury.
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.
Section 50567-7 (50567-7)

When using this product

Avoid contact with eyes.

Section 50570-1 (50570-1)

Do not apply to broken skin or open wounds. Avoid contact with eyes.

Section 51727-6 (51727-6)

Inactive ingredients:

  • Purified Water
  • Butyrospermum Parkii (Shea Butter)
  • Tocopherol (Vitamin E)
  • Tetrahexyldecyl Ascorbate (Vitamin C)
  • Allantoin
  • Aloe Barbadensis Leaf Juice
  • Calendula Officinalis Flower Extract
  • Centella Asiatica Extract
  • Portulaca Oleracea Extract
  • Cocos Nucifera (Coconut) Oil
  • Phytonadione (Vitamin K)
  • Escin
Section 53413-1 (53413-1)

Questions or comments?

Contact us at [email protected]

Section 53414-9 (53414-9)

If pregnant or breast-feeding

Ask a health professional before use

Section 55105-1 (55105-1)

Purpuse:Bruise Relief.

"HPUS" indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 55106-9 (55106-9)

Active ingredient:

  • Arnica Montana 1X HPUS (7%)
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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