83818-025

83818-025
SPL v1
SPL
SPL Set ID 3e41fc0e-54c3-2622-e063-6294a90a13c9
Route
TOPICAL
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (7 g)
Inactive Ingredients
Carbomer Ceramide Ap Niacinamide Aloe Barbadensis Leaf Alpha-tocopherol Ascorbic Acid Phytonadione Triethanolamine Phenoxyethanol Ceramide Np Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-08

Description

Arnica Montana 1X HPUS 7%

Purpose

Reduces pain, swelling, and discoloration from bruises


Medication Information

Purpose

Reduces pain, swelling, and discoloration from bruises

Description

Arnica Montana 1X HPUS 7%

Use

reduces symptoms of bruising such as: 1. pain 2. swelling 3. discoloration

Warnings

For external use only

Directions

Apply a thin layer of the cream to affected area and massage gently as soon as possible after minor bruise. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying the cream.

Do Not Use

if you are allergic to Arnica montana or to any of this product's inactive ingredients.

Active Ingredient

Arnica Montana 1X HPUS 7%

Other Information

• Store at room temperature (20–25 °C / 68–77 °F).

• Protect from freezing and excessive heat.

Inactive Ingredients

Aqua (Water), Niacinamide, Ceramide NP, Aloe Barbadensis Leaf Extract, Propylene Glycol, Tocopherol (Vitamin E), Phytonadione (Vitamin K1), Ascorbic Acid (Vitamin C), Ceramide AP, Phenoxyethanol, Carbomer, Triethanolamine

Questions Or Comments?

Please contact [email protected]

Principal Display Panel

When Using This Product

• avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin

• use only as directed

• do not tightly wrap or bandage the treated area

• do not apply heat or ice to the treated area immediately before or after use.

Stop Use and Ask A Doctor If

• condition persists for more than 3 days or worsens

• symptoms clear up and occur again within a few days.

Keep Out of Reach of Children

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


Structured Label Content

Use

reduces symptoms of bruising such as: 1. pain 2. swelling 3. discoloration

Purpose

Reduces pain, swelling, and discoloration from bruises

Warnings

For external use only

Directions

Apply a thin layer of the cream to affected area and massage gently as soon as possible after minor bruise. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying the cream.

Do Not Use (Do not use)

if you are allergic to Arnica montana or to any of this product's inactive ingredients.

Active Ingredient

Arnica Montana 1X HPUS 7%

Other Information (Other information)

• Store at room temperature (20–25 °C / 68–77 °F).

• Protect from freezing and excessive heat.

Inactive Ingredients (Inactive ingredients)

Aqua (Water), Niacinamide, Ceramide NP, Aloe Barbadensis Leaf Extract, Propylene Glycol, Tocopherol (Vitamin E), Phytonadione (Vitamin K1), Ascorbic Acid (Vitamin C), Ceramide AP, Phenoxyethanol, Carbomer, Triethanolamine

Questions Or Comments? (Questions or comments?)

Please contact [email protected]

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product (When Using this product)

• avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin

• use only as directed

• do not tightly wrap or bandage the treated area

• do not apply heat or ice to the treated area immediately before or after use.

Stop Use and Ask A Doctor If (Stop Use and ask a doctor if)

• condition persists for more than 3 days or worsens

• symptoms clear up and occur again within a few days.

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)