FDA.reportPublic FDA data

Leader Burn Relief Spray

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2025-06-10
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
legacy-cache
Hydrated at
2026-08-01 20:37:05

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

for temporary relief of pain and itching associated with: sunburn minor cuts scrapes minor burns insect bites minor skin irritations

Dosage and administration

shake can well for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily for children under 2 years of age: consult a doctor to apply to face, spray in palm of hand and gently apply

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of pain and itching associated with:

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

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Use only as directed. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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

  • do not get into eyes
  • ask a doctor before using on children under 2 years of age

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition gets worse
  • symptoms last more than 7 days or clear up and occur again in 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 Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake can well
  • for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • for children under 2 years of age: consult a doctor
  • to apply to face, spray in palm of hand and gently apply

Other information

OTHER SAFETY INFORMATION

store between 20°C to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, butane, carbomer, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerin, methylparaben, propane, propylene glycol, propylparaben, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, water

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader

Burn

Relief

Spray

Lidocaine 0.5%

External Analgesic

Relieves Pain &

Itching from

Sunburn, Minor

Burns & Insect Bites

Cools & Moisturizes

Sunburned Skin

NET WT 4.5 OZ (127 g)

Burn Relief SprayBurn Relief Spray

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0037-1GM - Gram70000-0037f0838461-8ee9-4d2a-85a3-8d092f16ca0012020-06-05

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
70000-003770000-0037-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
METHYLPARABENA2I8C7HI9TIACT
PROPANET75W9911L6IACT
PROPYLPARABENZ8IX2SC1OHIACT
BUTANE6LV4FOR43RIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT

Source Document#

Source XML

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
373c1c8f-a7ca-721a-e063-6394a90a24539c33ba66-0f4e-151a-e053-2995a90a2ced2025-06-10WarningsExact identifier
spl id: 373c1c8f-a7ca-721a-e063-6394a90a2453
spl set id: 9c33ba66-0f4e-151a-e053-2995a90a2ced

Reported adverse events (FAERS/openFDA)#

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