Leader Anti-Itch

Manufacturer: Cardinal Health | Natural Essentials
Effective date: 2018-01-24
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:04:25

Label at a glance#

ProductLeader Anti-Itch Maximum Strength

Active ingredientBENZOCAINE, RESORCINOL

Label structure10 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#

SPL UNCLASSIFIED SECTION

Drug Facts

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.

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 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

SPL UNCLASSIFIED SECTION

store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel - 28 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49781-092-01

Compare to Vagisil^®

Maximum Strength Cream

active ingredients*

LEADER^®

MAXIMUM STRENGTH

Anti-Itch Vaginal Cream

Fast, Long-Lasting Relief from Intense Itch

Associated with irritating Vaginal Conditions

For Feminine Itching & Irritation

Fast, Long-Lasting Relief from Intense Itch associated with:

Discharge and Irritating Vaginal Conditions

Satisfaction Guaranteed

NET WT 1 OZ (28g)

Principal Display Panel - 28 g Carton Label

Principal Display Panel - 28 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49781-092-01

Compare to Vagisil^®

Maximum Strength Cream

active ingredients*

LEADER^®

MAXIMUM STRENGTH

Anti-Itch Vaginal Cream

Fast, Long-Lasting Relief from Intense Itch

Associated with irritating Vaginal Conditions

Satisfaction Guaranteed

NET WT 1 OZ (28g)

Principal Display Panel - 28 g Tube Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49781-092-01	2025-01-09	C162847	48780-1	9d75b9d0-ecda-f424-e053-dadaa90a57ce	686ffefe-9685-423c-a50e-6129654675eb
49781-092-01	2020-01-31	C162847	48780-1	9d75b9d0-ecda-f424-e053-dadaa90a57ce	686ffefe-9685-423c-a50e-6129654675eb

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BENZOCAINE	ACTIVE INGREDIENT	U3RSY48JW5	1
RESORCINOL	ACTIVE INGREDIENT	YUL4LO94HK	1
BENZOCAINE	ACTIVE MOIETY	U3RSY48JW5	1
RESORCINOL	ACTIVE MOIETY	YUL4LO94HK	1
.Alpha.-Tocopherol	INACTIVE INGREDIENT	H4N855PNZ1	1
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	1
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked)	INACTIVE INGREDIENT	809Y72KV36	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	1
Glyceryl Monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	1
Isopropyl Palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	1
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	1
PEG-100 Stearate	INACTIVE INGREDIENT	YD01N1999R	1
Potassium Methylparaben	INACTIVE INGREDIENT	M64U971IB0	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	1
Trolamine	INACTIVE INGREDIENT	9O3K93S3TK	1
Vitamin A	INACTIVE INGREDIENT	81G40H8B0T	1
Vitamin D	INACTIVE INGREDIENT	9VU1KI44GP	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Leader Anti-Itch Maximum Strength
Benzocaine and Resorcinol
BENZOCAINE
RESORCINOL
Aloe Vera Leaf
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked)
Cetyl Alcohol
Edetate Disodium
Glyceryl Monostearate
Isopropyl Myristate
Isopropyl Palmitate
Lanolin
Potassium Methylparaben
Mineral Oil
PEG-100 Stearate
Propylene Glycol
Water
Stearic Acid
Stearyl Alcohol
Trolamine
Vitamin A
Vitamin D
.Alpha.-Tocopherol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49781-092	49781-092-01

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
BENZOCAINE	U3RSY48JW5	ACTIB
RESORCINOL	YUL4LO94HK	ACTIB
Aloe Vera Leaf	ZY81Z83H0X	IACT
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked)	809Y72KV36	IACT
Cetyl Alcohol	936JST6JCN	IACT
Edetate Disodium	7FLD91C86K	IACT
Glyceryl Monostearate	230OU9XXE4	IACT
Isopropyl Myristate	0RE8K4LNJS	IACT
Isopropyl Palmitate	8CRQ2TH63M	IACT
Lanolin	7EV65EAW6H	IACT
Potassium Methylparaben	M64U971IB0	IACT
Mineral Oil	T5L8T28FGP	IACT
PEG-100 Stearate	YD01N1999R	IACT
Propylene Glycol	6DC9Q167V3	IACT
Water	059QF0KO0R	IACT
Stearic Acid	4ELV7Z65AP	IACT
Stearyl Alcohol	2KR89I4H1Y	IACT
Trolamine	9O3K93S3TK	IACT
Vitamin A	81G40H8B0T	IACT
Vitamin D	9VU1KI44GP	IACT
.Alpha.-Tocopherol	H4N855PNZ1	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 343 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TOPICAL		7 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	GEL / TOPICAL		150 mg	Exact identifier — unii candidate 6 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	PELLET / SUBCUTANEOUS	0.97 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / VAGINAL		750 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, FOAM / TOPICAL		144 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL / TOPICAL	19.2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, DELAYED RELEASE / ORAL	1.7 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	EMULSION / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	FILM, EXTENDED RELEASE / TRANSDERMAL	187.5 mg		Exact identifier — unii candidate 8 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	CREAM / VAGINAL		425 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	AEROSOL / TOPICAL		397 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	OINTMENT / TOPICAL		569 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	FILM, SOLUBLE / BUCCAL	0.07 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	JELLY / TOPICAL	20 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET / ORAL	33.34 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	AEROSOL, METERED / RECTAL	ADJ PH		Exact identifier — unii candidate 22 equally ranked IID candidates
Glyceryl Monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	CAPSULE, EXTENDED RELEASE / ORAL		64 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Trolamine	TROLAMINE	9O3K93S3TK	AEROSOL, FOAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 22 equally ranked IID candidates
.Alpha.-Tocopherol	.ALPHA.-TOCOPHEROL	H4N855PNZ1	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.64 mg		Exact identifier — unii candidate 10 equally ranked IID candidates
Stearic Acid	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	EMULSION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / TOPICAL		5148 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL / TOPICAL	9.3 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		19 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	CREAM / TOPICAL		162000 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Edetate Disodium	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
Propylene Glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
Lanolin	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked)	CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	809Y72KV36	EMULSION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
Lanolin	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2b46b088-62ca-566b-e063-6294a90a1b0f			686ffefe-9685-423c-a50e-6129654675eb	2025-01-09	Warnings	Exact identifier spl set id: 686ffefe-9685-423c-a50e-6129654675eb

Reported adverse events (FAERS/openFDA)#

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