FDA Label for Leader Anti-itch Maximum Strength

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENTS
PURPOSE
USE
WARNINGS
OTC - WHEN USING
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
ADULTS AND CHILDREN 12 YEARS AND OLDER
CHILDREN UNDER 12 YEARS
OTHER INFORMATION
INACTIVE INGREDIENTS
PRINCIPAL DISPLAY PANEL - 28 G CARTON LABEL
PRINCIPAL DISPLAY PANEL - 28 G TUBE LABEL

Leader Anti-itch Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Active Ingredients

Benzocaine 20%

Resorcinol 3%

Purpose

External Analgesic

Use

temporarily relieves itching

Warnings

For external use only

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 - lea02 0000 01

Principal Display Panel - 28 G Tube Label