LIDAFLEX- lidocaine patch

LidaFlex by

Drug Labeling and Warnings

LidaFlex 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 4%

PURPOSE

Purpose:

Topical Anesthetic

INDICATIONS & USAGE

Uses:

For temporary relief of pain

WARNINGS

Warnings:

For external use only

DO NOT USE

Do not use

• More than 1 pathch at a time
• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product

WHEN USING

When using this product

• Use only as directed
• Avoid contact with the eyes, mucous membranes or rashes
• Do not bandage tightly

STOP USE

Stop use and ask a doctor if

• localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
• Conditions worsen
• Symptoms persist for more than 7 days
• Symptoms clear up and occur again within a few days

PREGNANCY OR BREAST FEEDING

If Pregnant or breast-feeding

Ask a health professional before use.

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.

DOSAGE & ADMINISTRATION

Directions

Adults and Children 12 years of age and over:

• Clean and dry the affected area
• Open pouch and remove one patch
• Apply 1 patch at a time to affected area; not more than 3 to 4 times daily
• Reseal pouch containing unused patches after each use
• Remove patch from the skin after at most 8-hour application ​

​Children under 12 years of age: Consult a doctor

OTHER SAFETY INFORMATION

Other information:

• Avoid storing product in direct sunlight
• Protect product from exceessive moisture

INACTIVE INGREDIENT

Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

PRINCIPAL DISPLAY PANEL

​Manufactured for:

SOLA Pharmaceuticals

655 Highlandia Dr. Ste B

Baton Rouge, LA 70810

For questions for comments call 866-747-7365

LidaFlex Patch

Topical Pain Patch

For temporay pain relief

NDC: 70512-012-30

Qty: 30 Flex Patches

(5 per Resealable Pouch) x 6

INGREDIENTS AND APPEARANCE

LIDAFLEX 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70512-012
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
FLAX SEED (UNII: 4110YT348C)
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: 70512-012-30	3 in 1 BOX	01/27/2021
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	01/27/2021

Labeler - SOLA Pharmaceuticals (080121345)