Label: MIRACLE ATO- glycerin cream

  • 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 22, 2014

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  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    oriental herb ext, green tea ext, adenosine, water, butylene glycol etc


  • PURPOSE

    for itching skin, lichenous skin trouble, skin balancing


  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE


    Wash your face with just warm water or a gentle face cleanser and pat dry.
    Apply Miracle ATO Moisture Cream to your entire face including the neck area to be needed.
    Wait for product to dry completely before going to other steps. Remember to use Miracle ATO daily.



  • WARNINGS

    - avoid direct sun exposure, keep it refrigerated or in cooler places
    - do not eat

  • DOSAGE & ADMINISTRATION

    for exernal use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    MIRACLE ATO  
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69309-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ADENOSINE (UNII: K72T3FS567)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69309-1001-180 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/22/2014
    Labeler - Dr. Ha Skin Lab Co. (689061833)
    Registrant - Dr. Ha Skin Lab Co. (689061833)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dr. Ha Skin Lab Co.689061833manufacture(69309-1001)
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