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    NDC 70000-0534-01 Leader 5 mg/g Details

    Leader 5 mg/g

    Leader is a TOPICAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by CARDINAL HEALTH, INC.. The primary component is LIDOCAINE HYDROCHLORIDE.

    Product Information

    NDC 70000-0534
    Product ID 70000-0534_ecb10671-a18a-69dc-e053-2995a90ab6d9
    Associated GPIs
    GCN Sequence Number n/a
    GCN Sequence Number Description n/a
    HIC3 n/a
    HIC3 Description n/a
    GCN n/a
    HICL Sequence Number n/a
    HICL Sequence Number Description n/a
    Brand/Generic n/a
    Proprietary Name Leader
    Proprietary Name Suffix After Sun Cooling
    Non-Proprietary Name Lidocaine Hydrochloride
    Product Type HUMAN OTC DRUG
    Dosage Form GEL
    Route TOPICAL
    Active Ingredient Strength 5
    Active Ingredient Units mg/g
    Substance Name LIDOCAINE HYDROCHLORIDE
    Labeler Name CARDINAL HEALTH, INC.
    Pharmaceutical Class Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH NOT FINAL
    Application Number part348
    Listing Certified Through 2024-12-31

    Package

    NDC 70000-0534-01 (70000053401)

    NDC Package Code 70000-0534-1
    Billing NDC 70000053401
    Package 226 g in 1 BOTTLE (70000-0534-1)
    Marketing Start Date 2019-11-04
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL 968b0056-3ab4-0a81-e053-2995a90ab69e Details

    Revised: 11/2022