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    NDC 43498-0319-30 Burkhart Topical Anesthetic 200 mg/g Details

    Burkhart Topical Anesthetic 200 mg/g

    Burkhart Topical Anesthetic is a DENTAL GEL in the HUMAN OTC DRUG category. It is labeled and distributed by Burkhart Dental Supply Inc. The primary component is BENZOCAINE.

    Product Information

    NDC 43498-0319
    Product ID 43498-319_d655d30d-d706-d85a-e053-2995a90a4540
    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 Burkhart Topical Anesthetic
    Proprietary Name Suffix n/a
    Non-Proprietary Name Benzocaine
    Product Type HUMAN OTC DRUG
    Dosage Form GEL
    Route DENTAL
    Active Ingredient Strength 200
    Active Ingredient Units mg/g
    Substance Name BENZOCAINE
    Labeler Name Burkhart Dental Supply Inc
    Pharmaceutical Class Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
    DEA Schedule n/a
    Marketing Category OTC MONOGRAPH NOT FINAL
    Application Number part356
    Listing Certified Through 2024-12-31

    Package

    NDC 43498-0319-30 (43498031930)

    NDC Package Code 43498-319-30
    Billing NDC 43498031930
    Package 30 g in 1 JAR (43498-319-30)
    Marketing Start Date 2018-06-01
    NDC Exclude Flag N
    Pricing Information N/A

    Standard Product Labeling (SPL)/Prescribing Information SPL aa09dcc0-e641-4c6d-8a84-ba890c0fce4c Details

    Revised: 1/2022