SPL v1
SPL
SPL Set ID 3b4993d4-1a42-067e-e063-6394a90a4a39
Route
TOPICAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (7 g)
Inactive Ingredients
Vitamin E Polyethylene Glycol Succinate Vitamin K-dependent Protein C Alcohol Sodium Hydroxide Vanillyl Butyl Ether Water Carbomer Coconut Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01
Description

Active ingredient, ...........................Arnica Montana HPUs 7%

Medication Information

Warnings and Precautions

Warnings

For external use only

. Do not use on broken skin

. Avoid contact with eyes

Indications and Usage

Uses

Temporarily relieves pain, swelling, and discoloration associated with

bruises, minor injuries, muscle soreness, and bumps.

Dosage and Administration

Directions

.Apply a thin layer of cream to the affected area as soon as possible after minor injury.

.Repeat 3 times a day as needed.

.If heat or ice is applied, wait 5 minutes before applying cream.

Description

Active ingredient, ...........................Arnica Montana 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 persists for more than 3 days or worsens, or if symptoms clear up and occur again within a few days.

Section 51727-6

Inactive ingredients

Purified Water, Vitamin K, Vitamin C , Vitamin E, Coconut oil, Alcohol

Carbomer, sodium Hydroxide, Vanillyl Butyl Ether

Section 51945-4

Section 55105-1

Purpose, .......................... Bruise & Pain Relief

Section 55106-9

Active ingredient, ...........................Arnica Montana HPUs 7%

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves pain, swelling, and discoloration associated with

bruises, minor injuries, muscle soreness, and bumps.

Dosage and Administration (34068-7)

Directions

.Apply a thin layer of cream to the affected area as soon as possible after minor injury.

.Repeat 3 times a day as needed.

.If heat or ice is applied, wait 5 minutes before applying cream.

Warnings and Precautions (34071-1)

Warnings

For external use only

. Do not use on broken skin

. Avoid contact with eyes

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 persists for more than 3 days or worsens, or if symptoms clear up and occur again within a few days.

Section 51727-6 (51727-6)

Inactive ingredients

Purified Water, Vitamin K, Vitamin C , Vitamin E, Coconut oil, Alcohol

Carbomer, sodium Hydroxide, Vanillyl Butyl Ether

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose, .......................... Bruise & Pain Relief

Section 55106-9 (55106-9)

Active ingredient, ...........................Arnica Montana HPUs 7%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:40.684313 · Updated: 2026-03-14T23:09:34.496634