Synoflex Patch

Synoflex Patch
SPL v5
SPL
SPL Set ID de2042c4-6c5e-7365-e053-2a95a90ada2a
Route
TOPICAL
Published
Effective Date 2022-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (40 mg)
Inactive Ingredients
Acrylic Acid

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-28

Description

Lidocaine Hcl 4% Menthol 5%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine Hcl 4% Menthol 5%

Uses

For the temporary relief of pain

Section 51945-4

​​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

Warnings

For external use only

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

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
Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Other Ingredients

Acrylic Adhesive

Active Ingredients

Lidocaine Hcl 4%

Menthol 5%

Questrions Or Comments?

866-747-7365

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.


Structured Label Content

Uses

For the temporary relief of pain

Section 51945-4 (51945-4)

​​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

Purpose

Topical Anesthetic

Warnings

For external use only

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

Do Not Use (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
Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Other Ingredients

Acrylic Adhesive

Active Ingredients

Lidocaine Hcl 4%

Menthol 5%

Questrions Or Comments? (Questrions or comments?)

866-747-7365

When Using This Product (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 (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 (If pregnant or breast-feeding)

ask a healthcare professional before use.

Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

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


Advanced Ingredient Data


Raw Label Data

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