LEADER ANTI-ITCH MAXIMUM STRENGTH- benzocaine and resorcinol cream

Leader Anti-Itch by

Drug Labeling and Warnings

Leader Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Natural Essentials. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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)

INGREDIENTS AND APPEARANCE

LEADER ANTI-ITCH   MAXIMUM STRENGTH
benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49781-092
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	200 mg  in 1 g
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK)	RESORCINOL	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49781-092-01	1 in 1 CARTON	05/19/2013
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	05/19/2013

Labeler - Cardinal Health (097537435)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Essentials		947484713	MANUFACTURE(49781-092)