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    NDC 60319-1001-01 Premium Whitening 35 mL/100mL Details

    Premium Whitening 35 mL/100mL

    Premium Whitening is a DENTAL GEL, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by Hankuk Bowonbio Co., Ltd. The primary component is HYDROGEN PEROXIDE.

    Product Information

    NDC 60319-1001
    Product ID 60319-1001_98daa928-8680-4e7a-e053-2a95a90ad104
    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 Premium Whitening
    Proprietary Name Suffix n/a
    Non-Proprietary Name HYDROGEN PEROXIDE
    Product Type HUMAN OTC DRUG
    Dosage Form GEL, DENTIFRICE
    Route DENTAL
    Active Ingredient Strength 35
    Active Ingredient Units mL/100mL
    Substance Name HYDROGEN PEROXIDE
    Labeler Name Hankuk Bowonbio Co., Ltd
    Pharmaceutical Class n/a
    DEA Schedule n/a
    Marketing Category UNAPPROVED DRUG OTHER
    Application Number n/a
    Listing Certified Through 2024-12-31

    Package

    NDC 60319-1001-01 (60319100101)

    NDC Package Code 60319-1001-1
    Billing NDC 60319100101
    Package 4.3 mL in 1 BOTTLE, PLASTIC (60319-1001-1)
    Marketing Start Date 2016-12-01
    NDC Exclude Flag N
    Pricing Information N/A
    << 60306-0115-05 60319-2001-01 >>

    Contents

    Standard Product Labeling (SPL)/Prescribing Information SPL 77d048e9-6f92-486b-b65b-b5a8e5ac3a35 Details

    Revised: 12/2019
    Document Id: 98daa928-8680-4e7a-e053-2a95a90ad104
    Set id: 77d048e9-6f92-486b-b65b-b5a8e5ac3a35
    Version: 2
    Effective Time: 20191203