FDA.reportPublic FDA data

Leader After Sun Cooling Gel

Manufacturer
CARDINAL HEALTH, INC.
Effective date
2022-11-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:49:38

Label at a glance#

ProductLeader After Sun Cooling
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

temporarily relieves pain and itching due to: minor skin irritations sunburn minor burns scrapes minor cuts insect bites

Dosage and administration

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: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

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

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. If contact occurs, rinse with water to remove.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • condition gets worse
  • symptoms last more than 7 days
  • symptoms 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 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.
  • children under 2 years of age: Ask a doctor

Other information

OTHER SAFETY INFORMATION

may stain some fabrics

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, water, isopropyl alcohol, propylene glycol, glycerin, triethanolamine, carbomer, polysorbate 80, diazolidinyl urea, menthol, disodium EDTA, yellow 5, blue 1

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CL13898E-FCL13898E-F

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-053470000-0534-1

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
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
POLYSORBATE 806OZP39ZG8HIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
ISOPROPYL ALCOHOLND2M416302IACT
GLYCERINPDC6A3C0OXIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
25159cc9-5aea-07d2-e063-6394a90ab48b968b0056-3ab4-0a81-e053-2995a90ab69e2024-10-22WarningsExact identifier
spl set id: 968b0056-3ab4-0a81-e053-2995a90ab69e

Reported adverse events (FAERS/openFDA)#

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