FDA.reportPublic FDA data

Arnicare Cream

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2026-05-20
Label type
HUMAN OTC DRUG LABEL
Version
21
Source
full-release
Hydrated at
2026-06-01 02:38:39

Label at a glance#

ProductARNICARE
Active ingredientARNICA MONTANA
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient**

Arnica montana 1X HPUS 7%

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

OTC - PURPOSE SECTION

Purpose*

Relieves minor muscle pain & stiffness, swelling from injuries, discoloration from bruises

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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 threated area immediately 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

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.

DOSAGE & ADMINISTRATION SECTION

  • 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.

INACTIVE INGREDIENT SECTION

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

alcohol, caprylyl glycol, carbomer, cetyl palmitate, glycerin, lauroyl, macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

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 carton end flaps are open

dispose of 1 year after opening

0.5 oz (14 g)

1.4 oz (40 g)

2.5 oz (70 g)

4.2 oz (120 g)

Pain Relief*

Muscle Pain & Stiffness Swelling from Injuries Bruises*

*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.

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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabellabellabellabellabellabellabellabellabellabellabel25082508

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Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130306962032555GTIN-13: 0306962032555
EAN-13: 0306962032555
GTIN-12: 306962032555
UPC-A: 306962032555
GTIN storage (14 digits): 00306962032555		arn cr 1.5 box.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9021-602023-03-03C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-602023-03-03C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-632023-03-03C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-632023-03-03C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-682023-03-03C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-682023-03-03C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-822023-03-03C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-822023-03-03C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-602023-01-30C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-602023-01-30C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-632023-01-30C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-632023-01-30C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-682023-01-30C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-682023-01-30C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-822023-01-30C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream
0220-9021-822023-01-30C16284748780-1f386c64a-0a36-0266-e053-dadaa90a7c1aArnicare Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9021-60ARNICARE40 g in 1 TUBECREAM4021
0220-9021-63ARNICARE70 g in 1 TUBECREAM7021
0220-9021-68ARNICARE14 g in 1 TUBECREAM1421
0220-9021-68ARNICARE1 in 1 BOXCREAM121
0220-9021-82ARNICARE1 in 1 BOXCREAM121
0220-9021-82ARNICARE120 g in 1 TUBECREAM12021
0220-9021-88ARNICARE2 in 1 BOXCREAM221
0220-9021-88ARNICARE120 g in 1 TUBECREAM12021

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 INGREDIENTO80TY208ZW7
ARNICA MONTANAACTIVE MOIETYO80TY208ZW7
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G7
ALCOHOLINACTIVE INGREDIENT3K9958V90M7
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U7
CARBOMER 934INACTIVE INGREDIENTZ135WT92087
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K7
GLYCERININACTIVE INGREDIENTPDC6A3C0OX7
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VP7
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X57
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I7
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B7
WATERINACTIVE INGREDIENT059QF0KO0R7

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90210220-9021-60, 0220-9021-63, 0220-9021-82, 0220-9021-68, 0220-9021-88

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
202025-12-12monthly-update2026-06-03 17:44:54

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 · 108 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
66 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
66 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
66 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
66 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CREAM / TOPICAL600 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
66 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
66 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
66 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
66 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
66 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
66 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CREAM / TOPICAL600 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
66 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
66 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CREAM / TOPICAL600 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
66 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208CREAM / TOPICAL600 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
66 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
ARNICAREARNICA MONTANALaboratoires Boiron542b41dd-f285-4e48-a67b-8e69523b143a2026-05-20WarningsExact identifier
ndc (package): 0220-9021-60
ndc (package): 0220-9021-68
ndc (package): 0220-9021-88
ndc (package): 0220-9021-63
ndc (package): 0220-9021-82
ndc (product): 0220-9021
ndc11 (package): 00220902188
ndc11 (package): 00220902160
ndc11 (package): 00220902182
ndc11 (package): 00220902168
ndc11 (package): 00220902163
spl id: 5242ebff-163f-ebd4-e063-6294a90a61df
spl set id: 542b41dd-f285-4e48-a67b-8e69523b143a

Reported adverse events (FAERS/openFDA)#

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