SPL v2
SPL
SPL Set ID 3dbe6e5b-1ca7-6941-e063-6294a90ab042
Route
TOPICAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (7 g)
Inactive Ingredients
Butyrospermum Parkii (shea) Butter Sodium Benzoate Aqua Sodium Citrate Alcohol Cocos Nucifera (coconut) Oil Sodium Hydroxide Carbomer Phytonadione Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-09-23

Description

Arnica montana 1X HPUS 7% The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

For the temporary relief of pain, swelling, and discoloration due to minor bruising, muscle overexertion, or skin discomfort.

Dosage and Administration

Apply a thin layer to the affected area 2–3 times daily. Gently massage into fragile or delicate skin areas. If heat or ice is applied, wait 5 minutes before applying Arnica Bruise Cream.

Description

Arnica montana 1X HPUS 7% The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 44425-7

Store at 68°–77°F(20°–25°C). Protect from heat and direct sunlight.

Section 50565-1

Keep out of reach of children. In case of ingestion, seek medical help or contact a Poison Control Center immediately.

Section 50566-9

Stop use and ask a doctor if condition worsens or symptoms persist for more than 3 days.

Section 50570-1

if you are allergic to Arnica Montana or any of the ingredients.

Section 51727-6

Aqua (Purified Water), Glycerin, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Ethanol,Carbomer, Sodium Citrate, Sodium Hydroxide, Phytonadione (Vitamin K1), Sodium Benzoate.

Section 51945-4

Section 53413-1

Email at: [email protected]

Section 55105-1

Relieves for Minor Bruises, Muscle Soreness & Swelling from injuries,discoloration associated with bruising.

Section 55106-9

Arnica montana 1X HPUS 7%

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 60561-8

Avoid contact with eyes, mucous membranes, or broken skin.


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain, swelling, and discoloration due to minor bruising, muscle overexertion, or skin discomfort.

Dosage and Administration (34068-7)

Apply a thin layer to the affected area 2–3 times daily. Gently massage into fragile or delicate skin areas. If heat or ice is applied, wait 5 minutes before applying Arnica Bruise Cream.

Warnings and Precautions (34071-1)

For external use only.

Section 44425-7 (44425-7)

Store at 68°–77°F(20°–25°C). Protect from heat and direct sunlight.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of ingestion, seek medical help or contact a Poison Control Center immediately.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or symptoms persist for more than 3 days.

Section 50570-1 (50570-1)

if you are allergic to Arnica Montana or any of the ingredients.

Section 51727-6 (51727-6)

Aqua (Purified Water), Glycerin, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Ethanol,Carbomer, Sodium Citrate, Sodium Hydroxide, Phytonadione (Vitamin K1), Sodium Benzoate.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email at: [email protected]

Section 55105-1 (55105-1)

Relieves for Minor Bruises, Muscle Soreness & Swelling from injuries,discoloration associated with bruising.

Section 55106-9 (55106-9)

Arnica montana 1X HPUS 7%

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Section 60561-8 (60561-8)

Avoid contact with eyes, mucous membranes, or broken skin.


Advanced Ingredient Data


Raw Label Data

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