FDA.reportPublic FDA data

SynoFlex Patch

Manufacturer
Sola Pharmaceuticals
Effective date
2025-12-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:20:44

Label at a glance#

ProductSynoFlex Patch
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure14 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hcl 4%

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

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

Other Ingredients

INACTIVE INGREDIENT SECTION

Acrylic Adhesive

Questrions or comments?

OTC - QUESTIONS SECTION

866-747-7365

PACKAGE LABEL.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

SnyoFlexSnyoFlex

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2600301lidocaine HCl 4 % / menthol 5 % Medicated PatchPSN5
2600301lidocaine hydrochloride 0.04 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD5
2600301lidocaine HCl 4 % / menthol 5 % Medicated PatchSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130070512015151GTIN-13: 0070512015151
EAN-13: 0070512015151
GTIN-12: 070512015151
UPC-A: 070512015151
GTIN storage (14 digits): 00070512015151		SynoFlex_carton 2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-015-15SynoFlex Patch3 in 1 BOXPATCH35
70512-015-15SynoFlex Patch5 g in 1 POUCHPATCH55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-015-15EA - Each70512-015c2f6ca05-6227-451b-9d84-c807ed7ad05e12022-06-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70512-01570512-015-15

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB
ACRYLIC ACIDJ94PBK7X8SIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SynoFlex PatchSYNOFLEX PATCHSola Pharmaceuticalsde2042c4-6c5e-7365-e053-2a95a90ada2a2025-12-08WarningsExact identifier
ndc (package): 70512-015-15
ndc (product): 70512-015
ndc11 (package): 70512001515
spl id: 4572a05d-f41c-883d-e063-6394a90ac5d2
spl set id: de2042c4-6c5e-7365-e053-2a95a90ada2a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.