FDA.reportPublic FDA data

Arnica Gel 15

Manufacturer
VITAMEDICA, INC.
Effective date
2024-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:38:15

Label at a glance#

ProductArnica Gel 15 Arnica Montana 1X HPUS
Active ingredientHYPERICUM PERFORATUM, SYMPHYTUM OFFICINALE WHOLE, ARNICA MONTANA WHOLE, RHUS TYPHINA WHOLE, HAMAMELIS VIRGINIANA BARK, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA FLOWER, LEDUM PALUSTRE WHOLE, ACHILLEA MILLEFOLIUM FLOWER, BELLADONNA LEAF, BELLIS PERENNIS FLOWER, RUTA GRAVEOLENS WHOLE
Label structure10 sections

Indications and uses

*Temporarily relieves these symptoms: • Bruising • Swelling • Pain • Stiff • Muscle Soreness  *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage and administration

Apply a thin layer of gel to target area. Reapply 3 times daily or as needed.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 200C HPUS.**

**The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States. This product has been manufactured at an FDA-regulated facility.

PURPOSE:

OTC - PURPOSE SECTION

Arnica Montana - Disoloration from bruising; relieves join and muscle pain, soreness & stiffness; relieves swelling from *

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

INDICATIONS & USAGE SECTION

*Temporarily relieves these symptoms:

• Bruising • Swelling • Pain • Stiff • Muscle Soreness 

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

For extrenal use only. Avoid contract with eyes and mucous membranes.

Do not use on open wounds or broken skin

Stop use or consult a physician if

• A rash or irritation occurs

• Symptoms persist for more than 7 days or worsen.

Keep this and all medications out of reach of children.

If sawllowed, seek medical attention or contact a Poison control center immediately.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical attention or contact a Poison Control Center immediately.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer of gel to target area. Reapply 3 times daily or as needed.

Other Information

OTHER SAFETY INFORMATION

Other Information

• Do not use if tamper evident seal is broken.

• Store at 68-77°F (20-25°C)

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Aloe Vera Leaf Juice Extract, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide, Ethanol

QUESTIONS:

OTC - QUESTIONS SECTION

Formulated and Distributed by

VitaMedica, Inc.

Tampa, FL 33624

©2024 VitaMedica, Inc.

www.vitamedica.com

888-367-8605

customerservice@vitamedica.com

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80004-400-40

Pain Relief*

VitaMedica

Arnica Gel + 15

Extra Strength Pain Relief

Arnica Gel + 15Arnica Gel + 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80004-400-40Arnica Gel 15Arnica Montana 1X HPUS85 g in 1 TUBEGEL851
80004-400-40Arnica Gel 15Arnica Montana 1X HPUS1 in 1 CARTONGEL11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80004-40080004-400-40

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPERICUM PERFORATUMXK4IUX8MNBACTIB
SYMPHYTUM OFFICINALE WHOLEH8FJJ6KX5YACTIB
ARNICA MONTANA WHOLEO80TY208ZWACTIB
RHUS TYPHINA WHOLEY465D8AABTACTIB
HAMAMELIS VIRGINIANA BARKIH3063S9MYACTIB
CALCIUM DISODIUM EDTA8U5D034955IACT
2-ETHYLHEXYL GLYCIDYL ETHERLU1UZ98B89IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
SODIUM HYDROXIDE55X04QC32IIACT
2-(ETHYLTHIO)ETHANOL6091RQ1378IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZACTIB
LEDUM PALUSTRE WHOLE1N8KG72C5MACTIB
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAACTIB
BELLADONNA LEAF6GZW20TIOIACTIB
ALOE VERA LEAF JUICERUE8E6T4NBIACT
BELLIS PERENNIS FLOWER26I94X9A1KACTIB
BENZYL ALCOHOLLKG8494WBHIACT
RUTA GRAVEOLENS WHOLE181JI0338PACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arnica Gel 15 Arnica Montana 1X HPUSARNICA GELVITAMEDICA, INC.4e56ff37-e260-be18-e063-6294a90aaced2024-03-31WarningsExact identifier
ndc (package): 80004-400-40
ndc (product): 80004-400
ndc11 (package): 80004040040
spl id: 4e5703a4-8d42-cd94-e063-6294a90a5a89
spl set id: 4e56ff37-e260-be18-e063-6294a90aaced

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.