FDA.reportPublic FDA data

Arnica Relief Cream

Manufacturer
Homeocare Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:36:42

Label at a glance#

ProductArnica Relief
Active ingredientARNICA MONTANA
Label structure8 sections

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 1x (HPUS) 7%

Purpose:

OTC - PURPOSE SECTION

As a topical aid for the relief of bruising, injuries, muscle aches, pain relief and pre-post surgically.

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

Indications for Usage:

INDICATIONS & USAGE SECTION

As a topical aid for the relief of bruising, injuries, muscle aches, pain relief and pre-post surgically.

Warnings:

WARNINGS SECTION

For external use only. Ask a doctor before use if pregnant or breastfeeding. Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Avocado Oil, Caprylyl Glycol, Cetyl Alcohol, Dimethicone, Dimethyl Taurate Copolymer, Glycerin USP, Glyceryl Stearate, Caprylic/Capric Triglyceride, Hexylen Glycol, Phenoxyethanol, Polyethylene, Sodium Polyacrylate, Potassium Sorbate, Purified Water, Sodium Acrylate/Sodium Acryloyl, Sunflower Oil.

Dosage & Administration:

DOSAGE & ADMINISTRATION SECTION

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).

Arnica Relief Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Arnica CreamArnica Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61727-112-03Arnica Relief56.7 g in 1 JARCREAM56.73

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC11
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75J1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR71
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ41
SODIUM ACRYLATEINACTIVE INGREDIENT7C98FKB43H1
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)INACTIVE INGREDIENT1DXE3F3OZX1
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2J1
SUNFLOWER OILINACTIVE INGREDIENT3W1JG795YI1
TRICAPRININACTIVE INGREDIENTO1PB8EU98M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61727-11261727-112-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOCADO OIL6VNO72PFC1IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL ALCOHOL936JST6JCNIACT
DIMETHICONE92RU3N3Y1OIACT
SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)1DXE3F3OZXIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
TRICAPRINO1PB8EU98MIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SODIUM ACRYLATE7C98FKB43HIACT
SUNFLOWER OIL3W1JG795YIIACT
ARNICA MONTANAO80TY208ZWACTIB

Source Document#

Source XML · Source PDF

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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HEXYLENE GLYCOLHEXYLENE GLYCOLKEH0A3F75JCREAM / TOPICAL385 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7CREAM / TOPICAL54.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4CREAM / TOPICAL0.25 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
2 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
Arnica ReliefARNICA MONTANAHomeocare Laboratories28a8e33e-cfae-4837-8b76-1bced9d700452026-01-12WarningsExact identifier
ndc (package): 61727-112-03
ndc (product): 61727-112
ndc11 (package): 61727011203
spl id: 48357808-f6d4-95fe-e063-6394a90a6c97
spl set id: 28a8e33e-cfae-4837-8b76-1bced9d70045

Reported adverse events (FAERS/openFDA)#

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