First Aid Burn Cream

Manufacturer
Water-Jel Technologies
Effective date
2017-11-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:53:13

Label at a glance#

ProductFirst Aid Burn
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

first aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts scrapes burns

Dosage and administration

adults and children 2 years of age and older:     clean the affected area     apply a small amount of this product on the area 1 to 3 times daily     may be covered with a sterile bandage     children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Lidocaine HCl  0.5%

Purpose

OTC - PURPOSE SECTION

First Aid antiseptic

External analgesic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection and for the temporary relief of pain and itching associated with

  • minor cuts
  • scrapes
  • burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
  • in large quantities, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites, or serious burns

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Stop use and ask a doctor if

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older:
  •     clean the affected area
  •     apply a small amount of this product on the area 1 to 3 times daily
  •     may be covered with a sterile bandage
  •     children under 2 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use if packet is opened or torn
  • you may report a serious reaction to this product to 800-275-3433

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, mineral oil, stearic acid, glyceryl stearate se, glycerin, Peg-100, cetyl alcohol, propylene glycol, diazolidinyl urea, methylparaben, propylparaben, aloe barbadensis leaf juice, triethanolamine, disodium EDTA

Questions?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid/Burn CreamFirst Aid/Burn Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN5
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD5
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY5

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
59898-902-01First Aid Burn0.9 g in 1 PACKETCREAM0.95
59898-902-01First Aid Burn1728 in 1 CARTONCREAM17285
59898-902-02First Aid Burn144 in 1 BOX, UNIT-DOSECREAM1445
59898-902-02First Aid Burn0.9 g in 1 PACKETCREAM0.95
59898-902-03First Aid Burn0.9 g in 1 PACKETCREAM0.95
59898-902-03First Aid Burn25 in 1 BOX, UNIT-DOSECREAM255
59898-902-36First Aid Burn0.9 g in 1 PACKETCREAM0.95

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59898-902FIRST AID BURN (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [WATER-JEL TECHNOLOGIES]5Current NDC, Legacy NDC, 7 package rows20171205_25ebf112-8ac3-4402-9a87-00e454ab7efa.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W74
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A4
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y4
LIDOCAINEACTIVE MOIETY98PI2009874
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW44
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K4
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE44
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP4
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK4
WATERINACTIVE INGREDIENT059QF0KO0R4

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59898-90259898-902-01, 59898-902-02, 59898-902-03, 59898-902-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 1 · 60 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PEG-100 STEARATEPEG-100 MONOSTEARATEYD01N1999RCREAM / TOPICAL552 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
5 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
5 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
5 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
First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies25ebf112-8ac3-4402-9a87-00e454ab7efa2017-11-30WarningsExact identifier
ndc (package): 59898-902-03
ndc (package): 59898-902-01
ndc (package): 59898-902-36
ndc (package): 59898-902-02
ndc (product): 59898-902
ndc11 (package): 59898090236
ndc11 (package): 59898090202
ndc11 (package): 59898090203
ndc11 (package): 59898090201
spl id: 5f3a0aa8-f1a3-6d47-e053-2a91aa0a77fa
spl set id: 25ebf112-8ac3-4402-9a87-00e454ab7efa

Reported adverse events (FAERS/openFDA)#

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