Lidosync Cream (Lidocaine 4%, Menthol 1%)

Manufacturer
iON Pharma, LLC
Effective date
2024-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:47

Label at a glance#

ProductLidoSync
Active ingredientLIDOCAINE HYDROCHLORIDE ANHYDROUS, LEVOMENTHOL
Label structure11 sections

Indications and uses

Uses: For Temporary relief of pain.

Label contents#

Full prescribing information#

LidoSync Drug Facts Active Ingredients

OTC - PURPOSE SECTION

Active ingredients: Purpose:

Lidocaine HCl 4%...................................Topical Anesthetic

Menthol 1%.............................................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Uses: For Temporary relief of pain.

LidoSync Warnings Do Not Use

WARNINGS SECTION

Do not use on large areas of the body or on cut, irritated or swollen skin on puncture wounds for more than one week without consulting a doctor

LidoSync When using section

OTC - WHEN USING SECTION

When using this product use only as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes • do not bandage or apply local heat (such as heating pads) to the area of use

LidoSync Stop use and consult doctor if section

OTC - STOP USE SECTION

Stop use and consult a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days

LidoSync If pregnant or breastfeeding section

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding: Ask a health professional before use.

Lidosync keep out of reach of children and pets section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control
Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults, or children over the age of 12: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
Children 12 years and younger: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe barbadensis Leaf Juice, Aminomethyl Propanol, Cetearyl
Alcohol (and) Dicetyl Phosphate (and) Ceteth-10 Phosphate, Cyclopentasiloxane (and) Dimethicone/Vinyl Dimethicone Crosspolymer,
Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, SD Alcohol, Steareth-21, Water.

Questions or comments section

OTC - QUESTIONS SECTION

Questions or Comments?
Call 833.711.8833 • info@ionpharmausa.com

Lidosync Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PanelPanel

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82944-200-01LidoSync1 in 1 CARTONCREAM11
82944-200-01LidoSync76.5 g in 1 BOTTLECREAM76.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82944-200LIDOSYNC (LIDOCAINE, MENTHOL) CREAM [ION PHARMA, LLC]1Current NDC, 2 package rows20240906_200f883c-439a-3b99-e063-6394a90aed10.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82944-200-01GM - Gram82944-20025785fc5-3824-441b-85f5-9d543150eb5a12025-03-04

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82944-20082944-200-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
LidoSyncLIDOCAINE, MENTHOLiON Pharma, LLC200f883c-439a-3b99-e063-6394a90aed102024-08-19WarningsExact identifier
ndc (package): 82944-200-01
ndc (product): 82944-200
ndc11 (package): 82944020001
spl id: 200f883c-439b-3b99-e063-6394a90aed10
spl set id: 200f883c-439a-3b99-e063-6394a90aed10

Reported adverse events (FAERS/openFDA)#

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