FDA.reportPublic FDA data

Arnicare Gel

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2025-07-21
Label type
HUMAN OTC DRUG LABEL
Version
25
Source
full-release
Hydrated at
2026-06-01 02:34:34

Label at a glance#

ProductArnicare
Active ingredientARNICA MONTANA
Label structure11 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 is officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Arnica montana 1X HPUS 7% Relieves muscle pain & stiffness, swelling from injuries, discoloration from bruises

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves muscle pain and stiffness due to:

  • minor injuries
  • overexertion
  • falls

reduces symptoms of bruising such as:

  • pain
  • swelling
  • discoloration

WARNINGS SECTION

Warnings

For external use only.

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

When using this product

avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin

use only as directed

dryness or irritation may occur

do not tightly wrap or bandage the treated area

do not apply heat or ice to treated 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

Directions

Apply a thin layer of Arnicare Gel to the affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Gel.A

Arnicare Gel Roll-On - Twist roller to the "ON" position and gently squeeze tube to apply a thin layer of product to affected area. Twist roller to the "OFF" position and continue massaging as needed. Repeat 3 times a day. If heat or ice is applied, wait 5 minutes before applying Arnicare Roll-on Gel.

INACTIVE INGREDIENT SECTION

Alcohol, carbomer, purified water, sodium hydroxide

SPL UNCLASSIFIED SECTION

Other information

do not use if glued carton end flaps are open or if the tube seal is broken

do not use if pouch is torn or open

Arnicare Gel 0.18 oz (5g)- dispose 1 day after opening

Arnicare Gel Roll-On (2023)- dispose of 1 year after opening

0.18 oz (5g)

0.5 oz (14g)

1.5 oz (45g)

2.6 oz (75g)

4.2 oz (120g)

3 oz (90g)

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.

OTC - QUESTIONS SECTION

Questions, Comments?

Distributed by Boiron, Inc., Newtown Square, PA 19073

1-800-BOIRON-1 (1-800-264-7661)

BoironUSA.com

Arnicare.com

Info@Boiron.com

Made in France

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

072925123072925123

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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9000-54Arnicare45 g in 1 TUBEGEL4525
0220-9000-54Arnicare1 in 1 PACKAGEGEL125
0220-9000-59Arnicare1 in 1 PACKAGEGEL125
0220-9000-59Arnicare75 g in 1 TUBEGEL7525
0220-9000-65Arnicare14 g in 1 TUBEGEL1425
0220-9000-65Arnicare1 in 1 PACKAGEGEL125
0220-9000-66Arnicare120 g in 1 TUBEGEL12025
0220-9000-66Arnicare1 in 1 PACKAGEGEL125
0220-9000-84Arnicare1 in 1 PACKAGEGEL125
0220-9000-84Arnicare45 g in 1 TUBEGEL4525
0220-9000-85Arnicare120 g in 1 TUBEGEL12025
0220-9000-85Arnicare2 in 1 PACKAGEGEL225
0220-9000-86Arnicare45 g in 1 TUBEGEL4525
0220-9000-86Arnicare2 in 1 PACKAGEGEL225
0220-9000-94Arnicare5 g in 1 POUCHGEL525

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0220-9000-54GM - Gram0220-9000cff869c1-d2d4-4a6b-b3c8-538129f7e9b512019-10-07
0220-9000-59GM - Gram0220-9000e3199ec0-b61f-46c0-bdc3-b278542c58fb12021-02-05
0220-9000-84GM - Gram0220-90005ecb73ed-c511-4676-8bff-f136e195c0d112021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW7
ARNICA MONTANAACTIVE MOIETYO80TY208ZW7
ALCOHOLINACTIVE INGREDIENT3K9958V90M7
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E7
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I7
WATERINACTIVE INGREDIENT059QF0KO0R7

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90000220-9000-66, 0220-9000-59, 0220-9000-54, 0220-9000-65, 0220-9000-84, 0220-9000-86, 0220-9000-94, 0220-9000-85

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
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 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
9 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 Boironce519152-e6fb-42e3-8fd4-f819476ebd862025-07-21WarningsExact identifier
ndc (package): 0220-9000-94
ndc (package): 0220-9000-86
ndc (package): 0220-9000-54
ndc (package): 0220-9000-84
ndc (package): 0220-9000-85
ndc (package): 0220-9000-66
ndc (package): 0220-9000-59
ndc (package): 0220-9000-65
ndc (product): 0220-9000
ndc11 (package): 00220900054
ndc11 (package): 00220900059
ndc11 (package): 00220900084
ndc11 (package): 00220900086
ndc11 (package): 00220900065
ndc11 (package): 00220900085
ndc11 (package): 00220900094
ndc11 (package): 00220900066
spl id: 3a728515-f1d3-bcb9-e063-6294a90a4910
spl set id: ce519152-e6fb-42e3-8fd4-f819476ebd86

Reported adverse events (FAERS/openFDA)#

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