LABOFLEX Arnipatch Muscle and Joint Patch

Manufacturer
Laboflex, Inc. | WOOSHIN LAPACHE d.o.o.
Effective date
2024-07-29
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:57:51

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

Adults and children 12 years of age and over ■ 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 - 7% 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

Adults and children 12 years of age and over

■ 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 ageConsult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Sodium, Glycerin, Methyl- paraben, Mint Oil, Partially Neutralized Polyacrylic Acid, Polysorbate 80, Povidone-K90, Propylparaben, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, 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

LabelLabel

CartonCarton

CartonCarton

LabelLabel

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83655-101LABOFLEX ARNIPATCH MUSCLE AND JOINT PATCH (ARNICA MONTANA) PATCH [LABOFLEX, INC.]9Unmatched20240731_069b3c7c-9464-e34f-e063-6394a90acade.zip

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
83655-10183655-101-15, 83655-101-21, 83655-101-05, 83655-101-22

Ingredients#

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

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

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
1e6c7c19-4260-4e38-e063-6294a90a57b1069b3c7c-9464-e34f-e063-6394a90acade2024-07-29WarningsExact identifier
spl id: 1e6c7c19-4260-4e38-e063-6294a90a57b1
spl set id: 069b3c7c-9464-e34f-e063-6394a90acade

Reported adverse events (FAERS/openFDA)#

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