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Leader Anti-Itch Regular Strength

Medically reviewed on January 24, 2018

Dosage form: cream
Ingredients: BENZOCAINE 50mg in 1g, RESORCINOL 20mg in 1g
Labeler: Cardinal Health
NDC Code: 49781-093

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.

Drug Facts

Active ingredients

Benzocaine 5%

Resorcinol 2%

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, 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)

LEADER ANTI-ITCH   REGULAR STRENGTH
benzocaine and resorcinol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49781-093
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE50 mg  in 1 g
RESORCINOL (RESORCINOL) RESORCINOL20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:49781-093-011 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/19/2014
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
Natural Essentials947484713MANUFACTURE(49781-093)

 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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