FDA.reportPublic FDA data

Leader Original Anti Itch Lotion

Manufacturer
CARDINAL HEALTH | Weeks & Leo Co., Inc. | Weeks & Leo
Effective date
2023-02-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:37:11

Label at a glance#

ProductLeader Anti-Itch
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure8 sections

Indications and uses

temporary relieves pain and itching due to: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac

Dosage and administration

to open, squeeze cap tightly and turn pump counter-clockwise adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.5%............................................................................................................................ External analgesic

Menthol 0.5%.............................................................................................................................. External analgesic

Uses

INDICATIONS & USAGE SECTION

temporary relieves pain and itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, poison oak, and poison sumac

Warning

WARNINGS SECTION

For external use only

ASk doctor before use

OTC - ASK DOCTOR SECTION

on chicken pox

on measles

when using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop Use and ask doctor if

OTC - STOP USE SECTION

condition worsens

symptoms last more than 7 days or clear up and occur 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.

Purpose

OTC - PURPOSE SECTION

Anti - itch

Directions

DOSAGE & ADMINISTRATION SECTION

to open, squeeze cap tightly and turn pump counter-clockwise

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer 940, cetyl alcohol, DMDM hydantoin, fragrance, glyceryl
stearate, isopropyl myristate, PEG-40 stearate, PEG-100 stearate,
purified water, sodium hydroxide, stearic acid, white petrolatum

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader original lotion.jpgLeader original lotion.jpg

Compare to Sarna Original Anti-Itch lotion

Original Formula Anti-Itch Lotion

Camphor 0.5%

Menthol 0.5%

Steroid Free

Relief from itching associated with dry skin, insectr bites, poison ivy and Sunburn

Cools and Soothes

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0546-1ML - Milliliter70000-0546b2398c74-4403-44a7-90c3-99f5bae4f75a12020-06-05

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
70000-054670000-0546-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
WATER059QF0KO0RIACT
PEG-40 STEARATEECU18C66Q7IACT
CETYL ALCOHOL936JST6JCNIACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
DMDM HYDANTOINBYR0546TOWIACT
SODIUM HYDROXIDE55X04QC32IIACT
CARBOMER 9404Q93RCW27EIACT
PETROLATUM4T6H12BN9UIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
GLYCERYL STEARATE SEFCZ5MH785IIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Anti-ItchCAMPHOR, MENTHOLLEADER/Cardinal Helath 110, Inc.9ca985c6-5017-0558-e053-2995a90a82022025-11-19WarningsExact identifier
ndc (product): 70000-0546
0e362027-4cb6-3a18-e063-6294a90a0e50f436a874-af26-416b-e053-2a95a90a10cb2024-01-05WarningsExact identifier
spl set id: f436a874-af26-416b-e053-2a95a90a10cb

Reported adverse events (FAERS/openFDA)#

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