LEADER MAXIMUM STRENGTH ANTI-ITCH- 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

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 (1-800-222-1222) 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, corn oil, disodium EDTA, fragrance, glyceryl stearate, isopropyl myristate, isopropyl palmitate, lanolin, methyl-4 hydroxybenzoate, mineral oil, PEG-100 stearate, propylene glycol, purified water, stearic acid, stearyl alcohol, triethanolamine, vitamin A, E & D.

Principal Display Panel - 200 mg Carton Label

LEADER™

NDC 70000-0369-1

Maximum Strength

Anti-Itch

Vaginal Cream

Benzocaine, 20% | Resorcinol, 3%

External Analgesic

Principal Display Panel - 200 mg Carton Label

Principal Display Panel - 200 mg Vial Label

LEADER™

NDC 70000-0369-1

Maximum Strength

Anti-Itch

Vaginal Cream

Fast, Long-Lasting Relief
from Intense Itch

Associated with Irritating Vaginal Conditions

NET WT 1 OZ (28 g)

Principal Display Panel - 200 mg Vial Label

LEADER MAXIMUM STRENGTH ANTI-ITCH
benzocaine and resorcinol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0369
Route of Administration	VAGINAL, TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70000-0369-1	1 in 1 CARTON	08/15/2019	09/30/2022
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/15/2019	09/30/2022

Labeler - Cardinal Health (097537435)

Name	Address	ID/FEI	Business Operations
Establishment
Natural Essentials		947484713	MANUFACTURE(70000-0369)

Revised: 3/2021

Document Id: 96e19ed0-959f-450a-8030-70a247698083

Set id: ef038a1f-e990-4a87-afa9-b3428e0fba4f

Version: 2

Effective Time: 20210324

Cardinal Health