FDA.reportPublic FDA data

LABOFLEX Arnipatch Muscle and Joint Patch

Manufacturer
Laboflex, Inc. | WOOSHIN LAPACHE d.o.o.
Effective date
2025-05-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:36:53

Label at a glance#

ProductLABOFLEX Arnipatch Muscle and Joint Patch
Active ingredientARNICA MONTANA
Label structure8 sections

Indications and uses

* For the temporary relief of muscle pain and stiffness due to minor injuries, overexertion and falls. Reduces pain, swelling and discoloration from bruises.

Dosage and administration

Keep out of reach of children ■ Clean and dry affected area ■ Remove patch from film ■ Place healing patch on intact skin ■ Patch may be worn up to 12 hours. Children under 12 years of age Consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Arnica Montana 1X - 1% HPUS

Purpose

OTC - PURPOSE SECTION

Muscle strain, Bruising

Uses

INDICATIONS & USAGE SECTION

  • * For the temporary relief of muscle pain and stiffness due to minor injuries, overexertion and
    falls. Reduces pain, swelling and discoloration from bruises.

Warnings

WARNINGS SECTION

For external use only.

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

When Using This Product

OTC - WHEN USING SECTION

When using this product■ Use only as directed ■ Do not bandage tightly ■ Avoid contact with eyes ■ Do not apply to open wounds or damaged skin

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Stop and ask doctor if

OTC - STOP USE SECTION

Stop and ask doctor if■Condition worsens ■ Irritation occurs ■ Symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

Keep out of reach of children

■ Clean and dry affected area ■ Remove patch from film ■ Place healing patch on intact skin ■ Patch may be worn up to 12 hours.

Children under 12 years of age Consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Sodium, Glycerin, Polyacrylic Acid, Polysorbate 80, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, 1,2-Hexandiol, Purified Water

Questions of comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-655-0252 or email: wooshinlabo-us@wooshinmed.com

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front label Pouch newFront label Pouch newFront label BoxFront label BoxFront labelFront label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130195685000046GTIN-13: 0195685000046
EAN-13: 0195685000046
GTIN-12: 195685000046
UPC-A: 195685000046
GTIN storage (14 digits): 00195685000046		Arnipatch_old 5patches.jpg
BarcodeEAN-130195685000343GTIN-13: 0195685000343
EAN-13: 0195685000343
GTIN-12: 195685000343
UPC-A: 195685000343
GTIN storage (14 digits): 00195685000343		ArniPatch Pouch BW_Pouch 5Patches (1).jpg
BarcodeEAN-130195685000350GTIN-13: 0195685000350
EAN-13: 0195685000350
GTIN-12: 195685000350
UPC-A: 195685000350
GTIN storage (14 digits): 00195685000350		Arnipatch_Box_NDC-83655-107-22_10 Patches.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83655-107-15LABOFLEX Arnipatch Muscle and Joint Patch5 g in 1 POUCHPATCH53
83655-107-21LABOFLEX Arnipatch Muscle and Joint Patch5 in 1 CARTONPATCH53
83655-107-21LABOFLEX Arnipatch Muscle and Joint Patch5 g in 1 PATCHPATCH53
83655-107-22LABOFLEX Arnipatch Muscle and Joint Patch10 in 1 CARTONPATCH103
83655-107-22LABOFLEX Arnipatch Muscle and Joint Patch5 g in 1 PATCHPATCH53

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83655-10783655-107-15, 83655-107-21, 83655-107-22

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
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
WATER059QF0KO0RIACT
TARTARIC ACIDW4888I119HIACT
ALCOHOL3K9958V90MIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
EDETATE SODIUMMP1J8420LUIACT
ARNICA MONTANAO80TY208ZWACTIB

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
LABOFLEX Arnipatch Muscle and Joint PatchARNICA MONTANALaboflex, Inc.28553d16-8284-777a-e063-6394a90a669c2025-05-19WarningsExact identifier
ndc (package): 83655-107-22
ndc (package): 83655-107-21
ndc (package): 83655-107-15
ndc (product): 83655-107
ndc11 (package): 83655010721
ndc11 (package): 83655010715
ndc11 (package): 83655010722
spl id: 494dc6dc-8246-6f2a-e063-6394a90a2ee6
spl set id: 28553d16-8284-777a-e063-6394a90a669c

Reported adverse events (FAERS/openFDA)#

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