FDA.reportPublic FDA data

Arnicare Leg Cramps

Manufacturer
Boiron | Boiron Inc.
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:26:00

Label at a glance#

ProductArnicare Leg Cramps
Active ingredientARNICA MONTANA, ZINC OXIDE, LACTIC ACID, L-
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients**

Arnica montana 9C HPUS (6.67 mg)

Sarcolacticum acidum 3C HPUS (6.67 mg)

Zincum oxydatum 3C (6.67 mg)

OTC - PURPOSE SECTION

Purpose*

Arnica montana 9C HPUS ... Temporarily relieves minor pain, stiffness & muscle soreness due to overexertion

Sarcolacticum acidum 3C HPUS ... Relieves muscle fatigue after prolonged exercise & muscle cramping

Zincum oxydatum 3C ... Relieves muscle cramping

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves minor muscle pain from cramps, stiffness, and muscular fatigue due to prolonged exercise and physical activity

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and older: Chew 1 tablet in the mouth immediately prior, during, and after physical activity every hour until symptoms improve, up to 10 tablets a day.

Children under 12 years of age: Not recommended.

SPL UNCLASSIFIED SECTION

do not use if glued carton end flaps are open or if the plastic sleeve around the tube is broken or missing

retain carton for full drug facts

contains 1.6 g of sugar per tablet

store below 77° F (25°C)

INACTIVE INGREDIENT SECTION

citric acide, dextrose, lactose, magnesium stearate, natural lemon flavor

SPL UNCLASSIFIED SECTION

3 Tubes 11 Tablets Each Total 33 Tablets

Natural lemon flavor

No Known Drug Interactions

Leg Cramp Relief*

Cramps Spasms*

Target Relief of main sources of exercise-induced muscle pain

*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

Quesions or comments?

Arnicare.com

BoironUSA.com

Info@Boiron.com

1-800-BOIRON-1

(1-800-264-7661)

Made in France

Distributed by: Boiron Inc.

Newtown Square, PA 19073-3267

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabellabellabelLabelLabelboxboxtubetube

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9073-062023-02-06C16284748780-1f386c649-c460-0266-e053-dadaa90a7c1aArnicare Leg Cramps
0220-9073-902023-02-06C16284748780-1f386c649-c460-0266-e053-dadaa90a7c1aArnicare Leg Cramps
0220-9073-062023-01-30C16284748780-1f386c649-c460-0266-e053-dadaa90a7c1aArnicare Leg Cramps
0220-9073-902023-01-30C16284748780-1f386c649-c460-0266-e053-dadaa90a7c1aArnicare Leg Cramps

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9073-06Arnicare Leg Cramps11 in 1 TUBETABLET115
0220-9073-90Arnicare Leg Cramps11 in 1 TUBETABLET115
0220-9073-90Arnicare Leg Cramps33 in 1 PACKAGETABLET335

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9073ARNICARE LEG CRAMPS (ARNICA MONTANA, LACTIC ACID, L-, ZINC OXIDE) TABLET [BOIRON]5Current NDC, Legacy NDC, 3 package rows20240208_6b658f98-d6e9-9ac9-e053-2991aa0ab3b0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90730220-9073-90, 0220-9073-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWACTIB
ZINC OXIDESOI2LOH54ZACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
MAGNESIUM STEARATE70097M6I30IACT
LACTIC ACID, L-F9S9FFU82NACTIB
DEXTROSE MONOHYDRATELX22YL083GIACT
LEMON24RS0A988OIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT

Source Document#

Source XML

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
Arnicare Leg CrampsARNICA MONTANA, LACTIC ACID, L-, ZINC OXIDEBoiron6b658f98-d6e9-9ac9-e053-2991aa0ab3b02024-02-01Exact identifier
ndc (package): 0220-9073-06
ndc (package): 0220-9073-90
ndc (product): 0220-9073
ndc11 (package): 00220907306
ndc11 (package): 00220907390
spl id: 1059edf1-c73b-9c04-e063-6294a90a1e1c
spl set id: 6b658f98-d6e9-9ac9-e053-2991aa0ab3b0

Reported adverse events (FAERS/openFDA)#

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