SPL v1
SPL
SPL Set ID 43417d4f-16c5-3c0f-e063-6294a90a23bb
Route
TOPICAL
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana Whole (5 g)
Inactive Ingredients
Alpha-tocopherol Water Glycerin Cocos Nucifera (coconut) Oil Grape Seed Oil Dimethicone Beeswax Niacinamide Hippophae Rhamnoides Fruit Oil Trehalose Propylene Glycol Phytonadione Lavender Oil Hydroxyethylcellulose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-13

Description

Arnica Montana 1x HPUS


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Reduces symptoms of bruising such as: Pain, Swelling, Discoloration

Dosage and Administration

Apply to affected area not more than 3–4 times daily.

Description

Arnica Montana 1x HPUS

Section 50565-1

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

Section 50567-7

Avoid contact with eyes, mucous membranes. If contact occurs, rinse with water.

Use only as directed

Do not tightly wrap or bandage the treated area.

Do not apply heat or ice to the treated area immediately.

Section 50570-1

Do not apply to open wounds or broken skin.

You are allergic to arnica montana, or other inactive ingredients in this product

Section 51727-6

Water, Glycerin, Cocos Nucifera (Coconut) Oil, Grape Seed Oil,Dimethicone, Beeswax, Acrylates Crosspolymer-6, Niacinamide, Hippophae

Rhamnoides Fruit Oil, Trehalose, Propylene Glycol, Phytonadione (Vitamin

K1), Hydroxyethylcellulose, Polyacrylamide, Vitamin E, Vitamin C, Lavender

Oil, Rosemary Leaf Oil, Boswellia Carterii (Frankincense) Oil, Panax

Notoginseng Root Extract, Liposomal Curcumin, Laureth-7, 1,2-Hexanediol,

pH Adjusters, Ethylhexylglycerin, Polysorbate 60.

Section 51945-4

Section 55105-1

Reduces pain, swelling, and discoloration from bruises

Section 55106-9

Arnica Montana 1x HPUS

Section 59845-8

Apply a thin layer of bruise cream to affected areas 3 times daily.

Massage gently until fully absorbed.

For best results, use consistently until appearance improves.

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)

Reduces symptoms of bruising such as: Pain, Swelling, Discoloration

Dosage and Administration (34068-7)

Apply to affected area not more than 3–4 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 50567-7 (50567-7)

Avoid contact with eyes, mucous membranes. If contact occurs, rinse with water.

Use only as directed

Do not tightly wrap or bandage the treated area.

Do not apply heat or ice to the treated area immediately.

Section 50570-1 (50570-1)

Do not apply to open wounds or broken skin.

You are allergic to arnica montana, or other inactive ingredients in this product

Section 51727-6 (51727-6)

Water, Glycerin, Cocos Nucifera (Coconut) Oil, Grape Seed Oil,Dimethicone, Beeswax, Acrylates Crosspolymer-6, Niacinamide, Hippophae

Rhamnoides Fruit Oil, Trehalose, Propylene Glycol, Phytonadione (Vitamin

K1), Hydroxyethylcellulose, Polyacrylamide, Vitamin E, Vitamin C, Lavender

Oil, Rosemary Leaf Oil, Boswellia Carterii (Frankincense) Oil, Panax

Notoginseng Root Extract, Liposomal Curcumin, Laureth-7, 1,2-Hexanediol,

pH Adjusters, Ethylhexylglycerin, Polysorbate 60.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Reduces pain, swelling, and discoloration from bruises

Section 55106-9 (55106-9)

Arnica Montana 1x HPUS

Section 59845-8 (59845-8)

Apply a thin layer of bruise cream to affected areas 3 times daily.

Massage gently until fully absorbed.

For best results, use consistently until appearance improves.

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

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