FDA.reportPublic FDA data

Arnicare Cream Value Pack

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 02:35:55

Label at a glance#

ProductArnica Value Pack
Active ingredientARNICA MONTANA
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients**

Arnicare Cream:
Arnica Montana 1X HPUS 7%

Arnica 30C pellets: (in each pellet)
Arnica montana 30C HPUS (0.44 mg)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Arnicare Cream: Arnica Montana 1X HPUS 7% Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

Arnica 30 C pellets: Arnica montana 30C HPUS (0.44 mg) Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

INDICATIONS & USAGE SECTION

Uses*

  • temporarily relieves minor muscle pain and stiffness due to:
  • minor injuries
  • overexertion
  • falls
  • reduces symptoms of bruising such as:
  • pain
  • swelling
  • discoloration

WARNINGS SECTION

Arnicare Cream:

For external use only.

OTC - DO NOT USE SECTION

Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
  • use only as directed
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area before or after use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition persists for more than 3 days or worsens
  • symptoms clear up and occur again within a few days

ARNICA 30 PELLETS:

Stop use and ask a doctor if symptoms persists for more than 3 days or worsen.

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

DOSAGE & ADMINISTRATION SECTION

ARNICARE CREAM:

  • Adults and children 1 year of age and older: Apply a thin layer of Arnicare Cream to affected area and massage gently as soon as possible after minor injury up to 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Cream.
  • Children under 1 year of age: Not recommended.

ARNICA 30C PELLETS:

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

ARNICARE CREAM: arachidyl alcohol, arachidyl glucoside, behenyl alcohol, Butyrospermum parkii (Shea) butter, coconut oil, glycerin, lactobacillus ferment, purified water, xanthan gum

ARNICA 30C PELLETS: lactose, sucrose

OTC - QUESTIONS SECTION

Arnicare.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

Distributed by Boiron Inc.

Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

do not use if glued end flaps are open or if pellet dispenser seal is broken

ARNICARE CREAM: dispose of 1 year after opening

retain carton for full drug facts

How to use Arnica 30C Pellets Turn tube upside down Twist until 5 pellets are dispensed Remove cap and pour pellets under tongue

2.5 oz (70 g)

+ Approx. 80 pellets

meltaway pellets

Pain Relief*

Muscle Pain & Stiffness Swelling from Injuries Bruises*

Local & General Muscle Pain

No known drug interactions

ɨ Homeopathic mother tincture made from Arnica montana fresh whole plant.

*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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9047-78Arnica Value Pack1 in 1 BOXKIT114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0220-9021-60GM - Gram0220-902181539eba-887c-421c-b1dc-82aa193727c612024-05-16
0220-9021-63GM - Gram0220-9021d381223e-d0c6-4f23-8399-bd728505691512021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW6
ARNICA MONTANAACTIVE MOIETYO80TY208ZW6
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G6
ALCOHOLINACTIVE INGREDIENT3K9958V90M6
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U6
CARBOMER 934INACTIVE INGREDIENTZ135WT92086
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X6
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K6
GLYCERININACTIVE INGREDIENTPDC6A3C0OX6
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VP6
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G6
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X56
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I6
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B6
SUCROSEINACTIVE INGREDIENTC151H8M5546
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90470220-9047-78
0220-0508
0220-9021

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
LACTOSEJ2B2A4N98GIACT
ARNICA MONTANAO80TY208ZWACTIB
GLYCERINPDC6A3C0OXIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
ARNICA MONTANAO80TY208ZWACTIB
DOCOSANOL9G1OE216XYIACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
COCONUT OILQ9L0O73W7LIACT

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 2 · 80 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GTABLET, EXTENDED RELEASE / ORAL400 mgExact identifier — unii+route
20 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii+route
31 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, SUGAR COATED / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CREAM / TOPICAL600 mgExact identifier — unii+route+dosage form
LACTOSELACTOSEJ2B2A4N98GSOLUTION / ORAL1682 mg/15mlExact identifier — unii+route
20 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
22 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii+route
31 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
LACTOSELACTOSEJ2B2A4N98GCONCENTRATE / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii+route
31 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii+route
20 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii+route
31 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
22 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii+route
20 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii+route
31 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii+route
20 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii+route
31 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
22 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
22 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii+route
31 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, DELAYED RELEASE / ORAL160 mgExact identifier — unii+route
20 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii+route
31 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
LACTOSELACTOSEJ2B2A4N98GCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii+route
20 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii+route
20 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii+route
31 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
LACTOSELACTOSEJ2B2A4N98GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route
20 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, DELAYED RELEASE / ORAL231.84 mgExact identifier — unii+route
20 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii+route
20 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii+route
31 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii+route
31 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii+route
20 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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARNICAREARNICA MONTANALaboratoires Boiron542b41dd-f285-4e48-a67b-8e69523b143a2026-05-20WarningsExact identifier
ndc (product): 0220-9021
ArnicaARNICA MONTANALaboratoires Boiron1ce3fd1f-24f8-491c-a0ae-087ea3d200402025-12-29Exact identifier
ndc (product): 0220-0508
Arnica Value PackARNICA MONTANALaboratoires Boironeeff33a9-44a7-413e-bae6-8183ef9a399f2025-12-15WarningsExact identifier
ndc (package): 0220-9047-78
ndc (product): 0220-9047
ndc11 (package): 00220904778
spl id: 4600f988-da06-56b7-e063-6394a90afd04
spl set id: eeff33a9-44a7-413e-bae6-8183ef9a399f

Reported adverse events (FAERS/openFDA)#

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