LENZAPRO FLEX- lidocaine/menthol patch

LenzaPro Flex by

Drug Labeling and Warnings

LenzaPro Flex by is a Otc medication manufactured, distributed, or labeled by SOLA Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients:

Lidocaine HCL 4%

Menthol 4%

PURPOSE

Purpose:

Topical Anesthetic

INDICATIONS & USAGE

Uses:

For the temporary relief of pain

WARNINGS

Warnings:

For external use

DO NOT USE

Do not use:

• More than 1 patch on your body at a time or on cut, iritated or swollen skin.
• On puncture wounds
• For more than 1 week without consulting a doctor

WHEN USING

When using this product:

• Use only as directed. Read and follow all directions and warnings on this label.
• Rare cases of serious burns have been reported with products of this type.
• Do not apply to wounds or damaged, broken or irritated skin.
• Do not allow contact with the eyes and mucous membranes.
• Do not bandage tightly or apply local heat (such as heating pads) to the area of use.
• Do not use at the same time as other topical analgesics.
• Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

STOP USE

Stop use and ask a doctor if:

• Condition worsens
• Redness is present
• Irritation developes
• Symptoms persist for more than 7 days or clear up and occur again within a few days.
• You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children and pets.

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

DOSAGE & ADMINISTRATION

Directions:

Adults and children over 12 years:

• Clean and dry the affected area.
• Open pouch and remove one patch.
• Remove the protective film from the patch and apply patch to the affected area.
• Reseal pouch containing unused patches after each use.
• Use 1 patch for up to 12 hours.

Children 12 years or younger:

• Ask a doctor

OTHER SAFETY INFORMATION

Other Information:

• Avoid storing product in direct sunlight
• Protect product from excessive mositure

INACTIVE INGREDIENT

Other Ingredients:

Acrylic Adhesive

PRINCIPAL DISPLAY PANEL

Questions or comments? 866-747-7365

Manufactured For:

SOLA Pharmaceuticals LLC

Baton Rouge, LA 70810

NDC: 70512-013-15

QTY: 15 Articulated patches (5 per Resealable Pouch) x 3

INGREDIENTS AND APPEARANCE

LENZAPRO FLEX 
lidocaine/menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70512-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ACRYLIC ACID (UNII: J94PBK7X8S)

Product Characteristics
Color		Score
Shape	RECTANGLE (White flexible patch)	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70512-013-15	3 in 1 BOX	02/01/2021
1		1 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	02/01/2021

Labeler - SOLA Pharmaceuticals (080121345)