FDA.reportPublic FDA data

Sonacaine Topical Anesthetic Gel With Menthol

Manufacturer
Filltech USA, LLC
Effective date
2023-11-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:59:45

Label at a glance#

ProductSonacaine Topical Anesthetic With Menthol
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

temporary relieves pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Dosage and administration

Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses:

INDICATIONS & USAGE SECTION

temporary relieves pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations

Warnings:

WARNINGS SECTION

For external use only.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age or older: Apply to affected area not more than 3 to 4 times daily.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Calendula Officinalis Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Chamomilla Recutita (Matricaria) Flower Extract, Diazolidinyl Urea, Disodium EDTA, Glycerin, Menthol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water, SD Alcohol 40-2, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine

Sonacaine Topical Anesthetic Gel With Menthol 2oz/60g (62221-935-02)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SonacaineSonacaine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291672lidocaine 4 % Topical GelPSN4
1291677sonacaine 4 % Topical GelPSN4
1291677lidocaine 0.04 MG/MG Topical Gel [Sonacaine]SBD4
1291672lidocaine 0.04 MG/MG Topical GelSCD4
1291672lidocaine 4 % Topical GelSY4
1291677Sonacaine 0.04 MG/MG Topical GelSY4
1291677Sonacaine 4 % Topical GelSY4

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62221-935-02Sonacaine Topical Anesthetic With Menthol60 g in 1 BOTTLEGEL604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62221-935SONACAINE TOPICAL ANESTHETIC WITH MENTHOL (LIDOCAINE) GEL [FILLTECH USA, LLC]4Current NDC, Legacy NDC, 1 package rows20231110_ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009871
LIDOCAINEACTIVE MOIETY98PI2009871
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YD1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839X1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW41
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62221-93562221-935-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMOMILEFGL3685T2XIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
COMFREY LEAFDG4F8T839XIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
6 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
6 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
6 equally ranked IID candidates

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
Sonacaine Topical Anesthetic With MentholLIDOCAINEFilltech USA, LLCca54c6da-4bf2-4e63-ba7f-a69c4f9c431a2023-11-09WarningsExact identifier
ndc (package): 62221-935-02
ndc (product): 62221-935
ndc11 (package): 62221093502
spl id: 09c2a084-c6bb-04eb-e063-6394a90adbcf
spl set id: ca54c6da-4bf2-4e63-ba7f-a69c4f9c431a

Reported adverse events (FAERS/openFDA)#

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