LEADER ANTI-ITCH  MAXIMUM STRENGTH - benzocaine and resorcinol cream 
Cardinal Health

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Benzocaine 20%

Resorcinol 3%

Purpose

External Analgesic

External Analgesic

Use

temporarily relieves itching

Warnings

For external use only

When using this product avoid contact with eyes

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

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, 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

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

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
LEADER ANTI-ITCH   MAXIMUM STRENGTH
benzocaine and resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-092
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Carbomer Copolymer Type B (Allyl Pentaerythritol Crosslinked) (UNII: 809Y72KV36)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Isopropyl Myristate (UNII: 0RE8K4LNJS)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
Lanolin (UNII: 7EV65EAW6H)  
Potassium Methylparaben (UNII: M64U971IB0)  
Mineral Oil (UNII: T5L8T28FGP)  
PEG-100 Stearate (UNII: YD01N1999R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Water (UNII: 059QF0KO0R)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Trolamine (UNII: 9O3K93S3TK)  
Vitamin A (UNII: 81G40H8B0T)  
Vitamin D (UNII: 9VU1KI44GP)  
.Alpha.-Tocopherol (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49781-092-011 in 1 CARTON05/19/2013
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/19/2013
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIBusiness Operations
Natural Essentials947484713MANUFACTURE(49781-092)

Revised: 1/2018
Document Id: 65823825-1cc7-4aae-a10d-63d9ebb2f940
Set id: 686ffefe-9685-423c-a50e-6129654675eb
Version: 2
Effective Time: 20180124
 
Cardinal Health