FDA.reportPublic FDA data

Leader Original Anti Itch Lotion

Manufacturer
LEADER/Cardinal Helath 110, Inc. | Weeks & Leo Co., Inc. | Weeks & Leo
Effective date
2025-11-19
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:17:20

Label at a glance#

ProductLeader Anti-Itch
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure9 sections

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#

OTC - ACTIVE INGREDIENT SECTION

Camphor 0.5%

Menthol 0.5%

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

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

on chicken pox

on measles

OTC - WHEN USING SECTION

do not get into eyes

OTC - STOP USE SECTION

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Anti-itch

External Analgesic

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 INGREDIENT SECTION

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

RECENT MAJOR CHANGES SECTION

Update to version number to the most recent label with updated inactive ingredient list

Updated Titles to remove repeats of Section Type

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel65-262-75v2.2 Back Label65-262-75v2.2 Back LabelCompare 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0546-12024-01-04C16284748780-1f386c64a-37ea-0266-e053-dadaa90a7c1aLeader Original Anti Itch Lotion
70000-0546-12023-01-30C16284748780-1f386c64a-37ea-0266-e053-dadaa90a7c1aLeader Original Anti Itch Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0546-1Leader Anti-Itch212 g in 1 BOTTLE, PUMPLOTION2127

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
70000-054670000-0546-1

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
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
WATER059QF0KO0RIACT
PEG-40 STEARATEECU18C66Q7IACT
CETYL ALCOHOL936JST6JCNIACT
PEG-100 STEARATEYD01N1999RIACT
STEARIC ACID4ELV7Z65APIACT
DMDM HYDANTOINBYR0546TOWIACT
SODIUM HYDROXIDE55X04QC32IIACT
PETROLATUM4T6H12BN9UIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
GLYCERYL STEARATE SEFCZ5MH785IIACT

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
Leader Anti-ItchCAMPHOR, MENTHOLLEADER/Cardinal Helath 110, Inc.9ca985c6-5017-0558-e053-2995a90a82022025-11-19WarningsExact identifier
ndc (package): 70000-0546-1
ndc (product): 70000-0546
ndc11 (package): 70000054601
spl id: 43fa4c6d-3b73-48ab-e063-6394a90ae0f4
spl set id: 9ca985c6-5017-0558-e053-2995a90a8202

Reported adverse events (FAERS/openFDA)#

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