LABOFLEX Calf & Arch Pain Relief Patch - lidocaine 4% and menthol 1%

Manufacturer
Laboflex, Inc. | WOOSHIN LAPACHE d.o.o.
Effective date
2023-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:25:22

Label at a glance#

ProductLABOFLEX Calf and Arch Pain Relief
Active ingredientLIDOCAINE, MENTHOL
Label structure13 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Adults and children 2 years of age and older: : apply to affecetd area not more than 3 to 4 times daily. Children under 2 years of age : do not use, consult a physiiacn. clean and dry affected area remove the film from the patch and apply to the affected area Use 1 patch at a time and not more than 3 to 4 times daily. Remove patch from the skin after at most 8 hours application

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aluminum Glycinate, Aluminum Hydroxide, Cellulose Gum, Glycerin, Methyl Acrylate,/2-Ethylhexyl Acrylate Copolymer, Methylparaben, Nonoxynol-30, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Silica, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Urea, Water

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: : apply to affecetd area not more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a physiiacn.

  • clean and dry affected area
  • remove the film from the patch and apply to the affected area
  • Use 1 patch at a time and not more than 3 to 4 times daily.
  • Remove patch from the skin after at most 8 hours application

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 Poison Control Center right away.

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Stop Use and Ask a Doctor if

OTC - STOP USE SECTION

Stop use and ask doctor if:

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Severe burning sensation, redness or irritation developss
  • You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

When Using This Product

OTC - WHEN USING SECTION

When using the product:

  • use only as directed.
  • do not bandage tightly
  • Avoid contact with the eyes, mucous membranes or rashes
  • do not apply to open wounds or damaged skin

Do not Use

OTC - DO NOT USE SECTION

Do not use:

  • On wounds or damaged skin
  • With a heantig pad
  • If you are allergic to any ingredients of this product

Warning

WARNINGS SECTION

For external use only

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Topical analgesic

Other information

SPL UNCLASSIFIED SECTION

Other Information:

  • Do not use if the pouch is open or damaged
  • Tighlty reseal the pouch containing unused patches
  • Store at room temperature
  • Do not freeze

Package / Principle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

Label FrontLabel Front

Label Drug FactsLabel Drug Facts

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83655-10483655-104-25, 83655-104-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
06998e14-88cf-4cd1-e063-6294a90a559206998e2c-2a00-045a-e063-6294a90a008d2023-09-30WarningsExact identifier
spl id: 06998e14-88cf-4cd1-e063-6294a90a5592
spl set id: 06998e2c-2a00-045a-e063-6294a90a008d

Reported adverse events (FAERS/openFDA)#

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