Germa Arnica Relief

Manufacturer
Caribe Natural LLC | Homeocare Laboratories Inc
Effective date
2015-06-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:06:45

Label at a glance#

ProductGerma Arnica Relief
Active ingredientARNICA MONTANA
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                                       Purpose

Arnica Montana 1X HPUS (4%)                    Pain, Bruises, Injuries, Muscle Aches

OTC - PURPOSE SECTION

Pain, Bruises, Inuries, Muscle Aches

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Germa Arnica Relief Gel

Homeopathic Medicine

Bruising & Swelling / Moreton e Hinchazon

Aches & Pains / Dolores y Molestia Muscular

Joints Pain / Dolores de Articulacion

Back Ache / Dolores de Espalda

Stiffness / Rigidez

Natural Pain Relief

DOSAGE & ADMINISTRATION SECTION

Directions:

For External Use Only. Apply generously to affected area, 2 to 3 times daily or as needed. Rub gently until complete absorption. Safe for children over 2 years old (under 2 years ask a Doctor).

WARNINGS SECTION

Warnings:

For External Use Only. Ask a Doctor before use if pregnant, or breast-feeding. When using this product: Do not get into eyes and do not apply on open skin. Stop use and ask a Doctor if: Condition worsens, symptoms last more than 7 days, or you are allergic to any of the ingredients.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: aloe vera, caprylyl glycol, hexylene glycol, hydroxyethylcellulose, phenoxyethanol, potassium sorbate, purified water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59561-100-022020-01-31C16284748780-19d75b9d0-1b13-f424-e053-dadaa90a57ce820c87ee-348f-4ccb-adb7-b4486f9a8d3f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59561-100-02Germa Arnica Relief57 g in 1 PACKAGEGEL572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59561-100GERMA ARNICA RELIEF (ARNICA MONTANA) GEL [CARIBE NATURAL LLC]2Legacy NDC, 1 package rows20150625_820c87ee-348f-4ccb-adb7-b4486f9a8d3f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW2
ARNICA MONTANAACTIVE MOIETYO80TY208ZW2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J2
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EP2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ42
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59561-10059561-100-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4EMULSION / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CONCENTRATE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JOINTMENT / TOPICAL12 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4AEROSOL, FOAM / TOPICAL8 mgExact identifier — unii candidate
19 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii candidate
4 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CAPSULE / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4PASTE / ORAL48 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4GRANULE, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii candidate
19 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPSOLUTION / TOPICAL0.6 %w/vExact identifier — unii candidate
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JSOLUTION / TOPICAL0.3 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JGEL / TOPICAL280 mgExact identifier — unii candidate
4 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SPRAY, METERED / NASAL0.06 mgExact identifier — unii candidate
19 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION/ DROPS / OPHTHALMIC0.47 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii candidate
19 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / RECTAL6.67 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, FILM COATED, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii candidate
19 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4LOTION / TOPICAL0.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates

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
2338666e-ffaf-455a-b4c2-0e47d29fabe4820c87ee-348f-4ccb-adb7-b4486f9a8d3f2015-06-24WarningsExact identifier
spl id: 2338666e-ffaf-455a-b4c2-0e47d29fabe4
spl set id: 820c87ee-348f-4ccb-adb7-b4486f9a8d3f

Reported adverse events (FAERS/openFDA)#

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