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

LABOFLEX Calf and Arch Pain Relief by

Drug Labeling and Warnings

LABOFLEX Calf and Arch Pain Relief by is a Otc medication manufactured, distributed, or labeled by Laboflex, Inc., WOOSHIN LAPACHE d.o.o.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

LABOFLEX CALF AND ARCH PAIN RELIEF- lidocaine 4% and menthol 1% patch 
Laboflex, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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

Active ingredient

Lidocaine 4%

Menthol 1%

Inactive ingredients

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:

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

Keep Out of Reach of Children

• If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant or Breast Feeding

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

Stop Use and Ask a Doctor if

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

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

Do not use:

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

Warning

For external use only

Uses

For the temporary relief of pain

Purpose

Topical anesthetic

Topical analgesic

Other information

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

LABOFLEX CALF AND ARCH PAIN RELIEF 
lidocaine 4% and menthol 1% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83655-104
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
UREA (UNII: 8W8T17847W)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
NONOXYNOL-30 (UNII: JJX07DG188)
METHYL ACRYLATE (UNII: WC487PR91H)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83655-104-25	5 in 1 BOX	09/27/2023
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 83655-104-11	1 in 1 POUCH; Type 0: Not a Combination Product	09/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	03/15/2022

Labeler - Laboflex, Inc. (128394050)

Registrant - Laboflex, Inc. (128394050)

Establishment
Name	Address	ID/FEI	Business Operations
WOOSHIN LAPACHE d.o.o.		507385209	manufacture(83655-104)

Revised: 9/2023

Document Id: 06998e14-88cf-4cd1-e063-6294a90a5592

34390-5

Set id: 06998e2c-2a00-045a-e063-6294a90a008d

Version: 1

Effective Time: 20230930