FDA.reportPublic FDA data

0498-0903: First Aid Burn Cream

Manufacturer
Honeywell Safety Products USA, Inc | Water-Jel Technologies
Effective date
2024-01-22
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:13:01

Label at a glance#

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

Indications and uses

prevent skin infection for temporary relief of pain associated with minor burns

Dosage and administration

adults and children 2 years of age and older: clean the affected area apply a small amount of this product (equal to the surface area of the tip of a finger) onto affected 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

  • prevent skin infection
  • for temporary relief of pain associated with minor burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in or near the eyes
  • if you are allergic to any of the ingredients
  • lin large areas of the body, particularly over raw surfaces or blistered areas
  • for more than 10 days

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days

Keep out of 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 (equal to the surface area of the tip of a finger) onto affected 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

  • tamper evident sealed packets
  • do not use if packet is opened or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis juice, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl stearate SE, methylparaben, mineral oil, PEG-100, propylene glycol, propylparaben, stearic acid, trolamine, water

Questions

OTC - QUESTIONS SECTION

1-800-430-5490

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Burn CreamFirst Aid Burn Cream

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
0498-09030498-0903-34

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
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
STEARIC ACID4ELV7Z65APIACT
METHYLPARABENA2I8C7HI9TIACT
PEG-100 STEARATEYD01N1999RIACT
CETYL ALCOHOL936JST6JCNIACT
EDETATE DISODIUM7FLD91C86KIACT
LIGHT MINERAL OILN6K5787QVPIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
1a514fae-b388-310a-e063-6294a90a5ade60dac908-afcf-5df2-e053-2a91aa0ae14b2024-06-07WarningsExact identifier
spl set id: 60dac908-afcf-5df2-e053-2a91aa0ae14b

Reported adverse events (FAERS/openFDA)#

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