Label: JNH A-CLEAR RESURFACE SULFUR- glycerin gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated October 15, 2014

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  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    sulfur, glycolic acid, cyclopentasiloxane, portulaca oleracea ext, dimethicone, ppg-15 stearyl ether


  • PURPOSE

    to treat acne


  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    apply appropriate amount twice a week


  • WARNINGS

    1) avoid direct sun exposure, keep it refrigerated or in cooler places
    2) gently tap on the packaging a few times before intake


  • DOSAGE & ADMINISTRATION

    for exernal use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    JNH A-CLEAR RESURFACE SULFUR 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53010-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53010-4001-150 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/15/2014
    Labeler - Daeduck Lab Co., Ltd. (557819376)
    Registrant - Daeduck Lab Co., Ltd. (557819376)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daeduck Lab Co., Ltd.557819376manufacture(53010-4001)
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