Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Arnica montana radix 30C HPUS Active ingredient**: See product name on front panel (**contains 0.443 mg of the active ingredient per pellet).
Arnica montana radix
- Manufacturer
- Boiron | Boiron, Inc.
- Effective date
- 2024-04-04
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:26:34
Key Label Information#
Uses
INDICATIONS & USAGE SECTION
Uses: See symptoms on front panel. Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises *
Warnings
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding , ask a health professional before use.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Other Label Information
INACTIVE INGREDIENT SECTION
lactose, sucrose
OTC - QUESTIONS SECTION
1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com Info@boiron.com Distributed by Boiron, Inc. Newtown Square, PA 19073
Label Images#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-0518-41 | 2023-08-29 | C162847 | 48780-1 | f386c649-9c95-0266-e053-dadaa90a7c1a | Arnica montana radix 30C |
| 0220-0518-41 | 2023-01-30 | C162847 | 48780-1 | f386c649-9c95-0266-e053-dadaa90a7c1a | Arnica montana radix 30C |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0220-0518-41 | Arnica montana radix | 30 [hp_C] in 1 TUBE | PELLET | 30 | 3 |
DailyMed Dashboard NDC Coverage#
Products#
- Arnica montana radix
- ANHYDROUS LACTOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-0518 | 0220-0518-41 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| ARNICA MONTANA ROOT | MUE8Y11327 | ACTIB |
| LACTOSE, UNSPECIFIED FORM | J2B2A4N98G | IACT |
| SUCROSE | C151H8M554 | IACT |
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Arnica montana radix 30C HPUS Active ingredient**: See product name on front panel (**contains 0.443 mg of the active ingredient per pellet).
INDICATIONS & USAGE SECTION
Uses: See symptoms on front panel. Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises *
OTC - STOP USE SECTION
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding , ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
DOSAGE & ADMINISTRATION SECTION
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
INACTIVE INGREDIENT SECTION
lactose, sucrose
SPL UNCLASSIFIED SECTION
Do not use if pellet dispenser seal is broken. Contains approx 80 pellets. How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue. *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. *C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
OTC - QUESTIONS SECTION
1-800-BOIRON-1 (1-800-264-7661), BoironUSA.com Info@boiron.com Distributed by Boiron, Inc. Newtown Square, PA 19073