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
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 01:04:28
Label at a glance#
ProductLeader Anti-Itch Regular Strength
Active ingredientBENZOCAINE, RESORCINOL
Label structure10 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredients
Benzocaine 5%
Resorcinol 2%
Purpose
External Analgesic
External Analgesic
Use
temporarily relieves itching
Warnings
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
Adults and children 12 years and older
apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily.
Children under 12 years
consult a doctor
Other information
store at 20°-25°C (68°-77°F)
Inactive ingredients
aloe vera gel, carbomer, cetyl alcohol, disodlum EDTA, fragrance, glyceryl stearate, isopropyl myristate, isopropyl palmitate, lanolin, mineral oil, methyl-4 hydroxybenzoate, PEG-100 stearate, propyl 4-hydroxybenzonate, propylene glycol, purified water, triethanolamine, vitamin A, E & D.
Principal Display Panel - 28 g Carton Label
NDC 49781-093-01
Compare to Vagisil®
Regular Strength Cream
active ingredients*
LEADER®
REGULAR STRENGTH
Anti-Itch Vaginal Cream
Fast Relief from Everyday Itch
Associated with Periods, Clothing, Perspiration
For Feminine Itching & Irritation
Fast Relief from Everyday Itch associated with
Periods, Clothing, Perspiration
Satisfaction Guaranteed
NET WT 1 OZ (28g)
Principal Display Panel - 28 g Tube Label
NDC 49781-093-01
Compare to Vagisil®
Regular Strength Cream
active ingredients*
LEADER®
REGULAR STRENGTH
Anti-Itch Vaginal Cream
Fast Relief from Everyday Itch
associated with Periods, Clothing, Perspiration
Satisfaction Guaranteed
NET WT 1 OZ (28g)
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0096295125856 | GTIN-13: 0096295125856 EAN-13: 0096295125856 GTIN-12: 096295125856 UPC-A: 096295125856 GTIN storage (14 digits): 00096295125856 | lea03-0000-01.jpg |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49781-093-01 | 2021-03-30 | C162847 | 48780-1 | 9d75b9d0-ece3-f424-e053-dadaa90a57ce | ee7298ed-e5e7-430b-bd69-baba4763f676 |
| 49781-093-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ece3-f424-e053-dadaa90a57ce | ee7298ed-e5e7-430b-bd69-baba4763f676 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49781-093-01 | GM - Gram | 49781-093 | 10ab616d-4c2c-4331-82bc-22f9ea66fc84 | 1 | 2019-04-11 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| 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 | |
| Propylparaben Sodium | INACTIVE INGREDIENT | 625NNB0G9N | 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.
- Leader Anti-Itch Regular 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
- Mineral Oil
- Potassium Methylparaben
- PEG-100 Stearate
- Propylparaben Sodium
- Propylene Glycol
- Water
- Trolamine
- Vitamin A
- Vitamin D
- .Alpha.-Tocopherol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 49781-093 | 49781-093-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glyceryl Monostearate | GLYCERYL MONOSTEARATE | 230OU9XXE4 | TABLET, DELAYED RELEASE / ORAL | 6 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SPRAY, METERED / NASAL | 4 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / AURICULAR (OTIC) | 0.01 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | AEROSOL, FOAM / RECTAL | 2 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRAVENOUS | 10 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / ORAL | 22602 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | GEL / TRANSDERMAL | 30 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | OINTMENT / TOPICAL | 7 %w/w | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| Lanolin | LANOLIN | 7EV65EAW6H | SPRAY / NASAL | NA | ||
| Isopropyl Myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | LOTION / TOPICAL | 50 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET / ORAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / ORAL | 4 mg | ||
| Propylparaben Sodium | PROPYLPARABEN SODIUM | 625NNB0G9N | SUSPENSION / ORAL | 16 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | DROPS / ORAL | NA | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL / TOPICAL | 1.16 %w/w | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | AEROSOL, FOAM / VAGINAL | 2 %w/w | ||
| Lanolin | LANOLIN | 7EV65EAW6H | OINTMENT / OPHTHALMIC | 3 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAVENOUS | 7 mg | ||
| PEG-100 Stearate | PEG-100 MONOSTEARATE | YD01N1999R | CREAM / VAGINAL | 100 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, DELAYED RELEASE / ORAL | 100 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION, EMULSION / INTRAVENOUS | 59 mg | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| Isopropyl Myristate | ISOPROPYL MYRISTATE | 0RE8K4LNJS | SPRAY / TOPICAL | 3665 mg | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | GEL / TRANSDERMAL | 6 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | GEL / TOPICAL | 150 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / TOPICAL | 0.75 %w/v | ||
| Propylparaben Sodium | PROPYLPARABEN SODIUM | 625NNB0G9N | TABLET, ORALLY DISINTEGRATING / ORAL | 0.1 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| Propylparaben Sodium | PROPYLPARABEN SODIUM | 625NNB0G9N | TABLET / ORAL | 0.06 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| Mineral Oil | MINERAL OIL | T5L8T28FGP | SPRAY / TOPICAL | 1379 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / RECTAL | 3315 mg | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | GEL, METERED / TRANSDERMAL | 14 mg | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRALESIONAL | 0.05 %w/v | ||
| Isopropyl Palmitate | ISOPROPYL PALMITATE | 8CRQ2TH63M | AEROSOL / TOPICAL | 397 mg | ||
| Cetyl Alcohol | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / RECTAL | 17 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / DENTAL | NA | ||
| Propylene Glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) | CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) | 809Y72KV36 | CREAM / TOPICAL | 2 mg | ||
| PEG-100 Stearate | PEG-100 MONOSTEARATE | YD01N1999R | LOTION / TOPICAL | 1 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, FILM COATED / ORAL | 4 mg | ||
| Lanolin | LANOLIN | 7EV65EAW6H | CREAM / VAGINAL | 2 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION / RESPIRATORY (INHALATION) | 0.01 %w/v | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| bbfe6fab-af33-4107-abba-c59c5d6242f2 | ee7298ed-e5e7-430b-bd69-baba4763f676 | 2020-03-25 | Warnings | ee7298ed-e5e7-430b-bd69-baba4763f676 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.