Leader Maximum Strength Anti-Itch

Manufacturer
Cardinal Health | Natural Essentials
Effective date
2021-03-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:48:21

Label at a glance#

ProductLeader Maximum Strength Anti-Itch
Active ingredientBENZOCAINE, RESORCINOL
Label structure9 sections

Dosage and administration

apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily. consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Resorcinol 3%

Purpose

OTC - PURPOSE SECTION

External Analgesic

Use

INDICATIONS & USAGE SECTION

temporarily relieves itching

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days. Also, do not use if you have an unusual or abnormal vaginal discharge except under the supervision of a physician.

OTC - DO NOT USE SECTION

Do not apply over large areas of the body

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older

SPL UNCLASSIFIED SECTION

apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.

Children under 12 years

SPL UNCLASSIFIED SECTION

consult a doctor

Other information

OTHER SAFETY INFORMATION

store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera gel, carbomer, cetyl alcohol, corn oil, disodium EDTA, fragrance, glyceryl stearate, isopropyl myristate, isopropyl palmitate, lanolin, methyl-4 hydroxybenzoate, mineral oil, PEG-100 stearate, propylene glycol, purified water, stearic acid, stearyl alcohol, triethanolamine, vitamin A, E & D.

Principal Display Panel - 200 mg Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0369-1

Maximum Strength

Anti-Itch

Vaginal Cream

Benzocaine, 20% | Resorcinol, 3%

External Analgesic

Principal Display Panel - 200 mg Carton Label
Principal Display Panel - 200 mg Carton Label

Principal Display Panel - 200 mg Vial Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0369-1

Maximum Strength

Anti-Itch

Vaginal Cream

Fast, Long-Lasting Relief
from Intense Itch

Associated with Irritating Vaginal Conditions

NET WT 1 OZ (28 g)

Principal Display Panel - 200 mg Vial Label
Principal Display Panel - 200 mg Vial Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0369-12021-03-30C16284748780-1ba0f9c33-1e29-a910-e053-dadaa90a0b85Drug Facts
70000-0369-12021-01-29C16284748780-1ba0f9c33-1e29-a910-e053-dadaa90a0b85Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0369-1GM - Gram70000-03692159307c-3d61-4058-a192-cf9a7d2eb26e12020-09-14

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-036970000-0369-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
96e19ed0-959f-450a-8030-70a247698083ef038a1f-e990-4a87-afa9-b3428e0fba4f2021-03-24WarningsExact identifier
spl id: 96e19ed0-959f-450a-8030-70a247698083
spl set id: ef038a1f-e990-4a87-afa9-b3428e0fba4f

Reported adverse events (FAERS/openFDA)#

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