SPL v7
SPL
SPL Set ID e1e48bd1-e924-41d4-a5eb-23c33309fa06
Route
ORAL
Published
Effective Date 2020-05-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (6 [hp_X])
Inactive Ingredients
Dextrose Monohydrate Magnesium Stearate Maltodextrin Lemon Oil

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 14 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-05-01
Description

Natural Homeopathic Arnica 6X, Arnica 12X, Arnica 30X

Medication Information

Description

Natural Homeopathic Arnica 6X, Arnica 12X, Arnica 30X

Warning

If symptoms persist more than 7 days or worsen, consult a physician.

Keep out of children’s reach.In case of overdose, get medical help or contact a poison control center right away.

If pregnant or breast-feeding, ask a doctor before use.

Do not use if shrink wrap is broken or missing.

Indications

For temporary relief of aching, strained muscles, bumps and bruises. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Directions 

Adults & children over 8: dissolve one lozenge in mouth. Repeat every half hour as needed.

Product Label

Active Ingredient

Natural Homeopathic Arnica 6X, Arnica 12X, Arnica 30X

Inactive Ingredients:

Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, tangerine flavor.

4 calories per lozenge. 1 gram sugar per lozenge.

No gluten added. Vegan.

Structured Label Content

Warning

If symptoms persist more than 7 days or worsen, consult a physician.

Keep out of children’s reach.In case of overdose, get medical help or contact a poison control center right away.

If pregnant or breast-feeding, ask a doctor before use.

Do not use if shrink wrap is broken or missing.

Indications

For temporary relief of aching, strained muscles, bumps and bruises. These uses are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Directions 

Adults & children over 8: dissolve one lozenge in mouth. Repeat every half hour as needed.

Product Label (Product label)

Active Ingredient (Active ingredient)

Natural Homeopathic Arnica 6X, Arnica 12X, Arnica 30X

Inactive Ingredients:

Dextrose Monohydrate, Magnesium Stearate, Maltodextrin, tangerine flavor.

4 calories per lozenge. 1 gram sugar per lozenge.

No gluten added. Vegan.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:13.599879 · Updated: 2026-03-14T23:13:25.872506