FDA.reportPublic FDA data

FSK-5

Manufacturer
Water-Jel Technologies
Effective date
2017-12-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:53:23

Label at a glance#

ProductFSK-5
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

for the temporary relief of pain associated with minor burns

Dosage and administration

adults and children 2 years of age and older; apply to affected area not more than 3 to 4 times daily spread a thick even layer over affected skin children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2.0 %

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain associated with minor burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on large areas of the body

on broken, blistered or oozing skin

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsens
  • symptoms persist for more than 7 days
  • symptoms clears up and occur again in a few days

Keep out of the reach of children

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 2 years of age and older; apply to affected area not more than 3 to 4 times daily
  • spread a thick even layer over affected skin
  • children under 2 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • do not use packeet if opened or torn
  • you may report a serious adverse reaction to this product to 800-275-3433

Inactive ingredients

INACTIVE INGREDIENT SECTION

triethanolamine, meleleuca alternifolia (tea tree) leaf oil, glycerin, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, carbomer, octoxynol-9, acrylates C/10-30 alkyl acrylate, disodium EDTA

SPL UNCLASSIFIED SECTION

MEDICAL DEVICES 
 2 2" x 6" Burn Dressings
 2 4" x 4" Burn Dressings
 112" x 16" Face Mask
 1 2" x 2.2 yd Elastic Bandage

 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of PDPimage of PDP

Principal Display Panel Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn JelBurn Jel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011852lidocaine HCl 2 % Topical GelPSN5
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD5
1011852lidocaine hydrochloride 2 % Topical JellySY5

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
59898-170-43FSK-51 in 1 KITKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-170FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]5Current NDC, Legacy NDC, 1 package rows20171212_4c62196a-9f94-4823-b95f-447f012f10bf.zip
59898-200FSK-5 (LIDOCAINE HYDROCHLORIDE) KIT [WATER-JEL TECHNOLOGIES]5Current NDC, Legacy NDC20171212_4c62196a-9f94-4823-b95f-447f012f10bf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A4
LIDOCAINEACTIVE MOIETY98PI2009874
CARBOMER HOMOPOLYMER TYPE BINACTIVE INGREDIENTHHT01ZNK314
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW44
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
OCTOXYNOL-9INACTIVE INGREDIENT7JPC6Y25QS4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK4

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59898-17059898-170-43
59898-20059898-200-35, 59898-200-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
TEA TREE OILVIF565UC2GIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
TROLAMINE9O3K93S3TKIACT
OCTOXYNOL-97JPC6Y25QSIACT
CARBOMER HOMOPOLYMER TYPE BHHT01ZNK31IACT
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE DISODIUM7FLD91C86KIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE BCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31GEL / TOPICAL81 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
OCTOXYNOL-9OCTOXYNOL-97JPC6Y25QSGEL / TOPICAL2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE BCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31GEL / TOPICAL81 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
9 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
9 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
9 equally ranked IID candidates
OCTOXYNOL-9OCTOXYNOL-97JPC6Y25QSGEL / TOPICAL2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
OCTOXYNOL-9OCTOXYNOL-97JPC6Y25QSGEL / TOPICAL2 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE BCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31GEL / TOPICAL81 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
9 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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
ndc (package): 59898-200-15
ndc (package): 59898-200-35
ndc (product): 59898-200
ndc11 (package): 59898020035
ndc11 (package): 59898020015
FSK-5LIDOCAINE HYDROCHLORIDEWater-Jel Technologies4c62196a-9f94-4823-b95f-447f012f10bf2017-12-07WarningsExact identifier
ndc (package): 59898-200-15
ndc (package): 59898-170-43
ndc (package): 59898-200-35
ndc (product): 59898-170
ndc11 (package): 59898020035
ndc11 (package): 59898020015
ndc11 (package): 59898017043
spl id: 5fc0e70e-35a7-6fdd-e053-2a91aa0ad0b3
spl set id: 4c62196a-9f94-4823-b95f-447f012f10bf
EBSS-5LIDOCAINE HYDROCHLORIDEWater-Jel Technologies7e21b96a-3d89-4d1c-9ec6-0611f6c9c6252017-12-07WarningsExact identifier
ndc (package): 59898-200-35
ndc11 (package): 59898020035
IWK-5LIDOCAINE HYDROCHLORIDEWater-Jel Technologiesf291841e-ccbd-4f5a-b1de-4cf596a167e32017-12-07WarningsExact identifier
ndc (package): 59898-200-15
ndc (package): 59898-200-35
ndc11 (package): 59898020035
ndc11 (package): 59898020015
EBSL-5LIDOCAINE HYDROCHLORIDEWater-Jel Technologies0d2631c1-93fc-478c-afed-0f175a7e85552017-12-07WarningsExact identifier
ndc (package): 59898-200-35
ndc11 (package): 59898020035

Reported adverse events (FAERS/openFDA)#

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