SynoFlex Patch by Sola Pharmaceuticals SYNOFLEX PATCH patch

SynoFlex Patch by

Drug Labeling and Warnings

SynoFlex Patch by is a Otc medication manufactured, distributed, or labeled by Sola Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Lidocaine Hcl 4%

Menthol 5%

Purpose

Topical Anesthetic

Uses

For the temporary relief of pain

Warnings

For external use only

Do not use

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

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 a 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 and ask a doctor if

• condition worsens
• redness is present
• irritation develops
• 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

If pregnant or breast-feeding

ask a healthcare professional before use.

Keep out of reach of children and pets

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

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 Information

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

Other Ingredients

Acrylic Adhesive

Questrions or comments?

866-747-7365

PRINCIPAL DISPLAY PANEL

​​Manufactured for:

Sola Pharmaceuticals LLC

Baton Rouge, LA 70810

SynoFlex Patch

Topical Pain Patch

For temporary relief of pain

NDC: 70512-015-15

Qty: 15 Flex Patches

(5 per Resealable Pouch) x 3

INGREDIENTS AND APPEARANCE

SYNOFLEX PATCH 
synoflex patch patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70512-015
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	40 mg  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 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: 70512-015-15	3 in 1 BOX	04/28/2022
1		5 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	04/28/2022

Labeler - Sola Pharmaceuticals (080121345)