Burn Spray

Manufacturer
Water-Jel Technologies
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:52:23

Label at a glance#

ProductBurn Mist
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

for the temporary relief of pain associated with minor burns

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2%

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

in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days
  • condition clears up and occurs again within 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.

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

diazolidinyl urea, edetate disodium, glycerin, hypromellose, methylparaben, octoxynol 9, propylene glycol, propylparaben, purified water, tea tree oil, trolamine

Questions or comments?

OTC - QUESTIONS SECTION

1-800-275-3433   info@waterjel.com   www.waterjel.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burn SrayBurn Sray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010769lidocaine HCl 2 % Topical SprayPSN8
1010769lidocaine hydrochloride 20 MG/ML Topical SpraySCD8
1010769lidocaine hydrochloride 2 % Topical SpraySY8

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-130743537500017GTIN-13: 0743537500017
EAN-13: 0743537500017
GTIN-12: 743537500017
UPC-A: 743537500017
GTIN storage (14 digits): 00743537500017
Principal Display Panel.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
59898-201-10Burn Mist59 mL in 1 BOTTLE, SPRAYSPRAY598
59898-201-20Burn Mist24 in 1 CASESPRAY248

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A4
LIDOCAINEACTIVE MOIETY98PI2009874
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW44
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WO4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
OCTOXYNOL 9INACTIVE INGREDIENT7JPC6Y25QS4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59898-20159898-201-10, 59898-201-20

Ingredients#

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

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

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 4 · 237 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii+route
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii+route
69 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii+route
69 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route
69 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route
39 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii+route
39 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii+route
69 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4LOTION / TOPICAL3 %w/wExact identifier — unii+route
9 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOSHAMPOO / TOPICAL3 %w/wExact identifier — unii+route
15 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCREAM / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii+route
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
48 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOSHAMPOO / TOPICAL3 %w/wExact identifier — unii+route
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route
69 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii+route
69 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii+route
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii+route
69 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii+route
69 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii+route
69 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii+route
69 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii+dosage form
48 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOJELLY / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii+dosage form
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
OCTOXYNOL 9OCTOXYNOL-97JPC6Y25QSGEL / TOPICAL2 mgExact identifier — unii+route
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii+route
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii+route
69 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii+route
39 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / NASAL1 mgExact identifier — unii+dosage form
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii+route
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii+route
39 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
69 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route
42 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii+route
39 equally ranked IID candidates
OCTOXYNOL 9OCTOXYNOL-97JPC6Y25QSLOTION / TOPICAL5 mgExact identifier — unii+route
9 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOCREAM / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
OCTOXYNOL 9OCTOXYNOL-97JPC6Y25QSSPONGE / TOPICAL5 %w/wExact identifier — unii+route
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route
48 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, FOAM / TOPICAL2.6 %w/wExact identifier — unii+route
42 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4OINTMENT / TOPICAL0.1 %w/wExact identifier — unii+route
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii+route
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii+route
48 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPONGE / TOPICAL11 %w/wExact identifier — unii+route
42 equally ranked IID candidates
HYPROMELLOSEHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii+route
15 equally ranked IID candidates
OCTOXYNOL 9OCTOXYNOL-97JPC6Y25QSSPONGE / TOPICAL5 %w/wExact identifier — unii+route
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii+route
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii+route
39 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route
39 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
39 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route
39 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route
42 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKPOWDER / TOPICAL0.02 mg/mgExact identifier — unii+route
42 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii+dosage form
39 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii+dosage form
69 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
Burn MistLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesc53ab9dd-351a-400b-b873-4f396e0af54d2026-03-31WarningsExact identifier
ndc (package): 59898-201-10
ndc (package): 59898-201-20
ndc (product): 59898-201
ndc11 (package): 59898020110
ndc11 (package): 59898020120
spl id: 4e590d19-e9bc-a8b3-e063-6294a90a64a1
spl set id: c53ab9dd-351a-400b-b873-4f396e0af54d

Reported adverse events (FAERS/openFDA)#

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