Label: CORAL S- glycerin soap

  • Category: HUMAN OTC DRUG LABEL

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 March 2, 2014

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  • ACTIVE INGREDIENT

    glycerin


  • INACTIVE INGREDIENT

    coconut soap chip, coral powder, titanium dioxide, edta-4na, lapa 5020, propolis, s-lact, jojoba oil, pg-4000, perfume


  • PURPOSE

    skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    apply every morning and night


  • WARNINGS

    A. Please stop using the product in anyone of the following cases:
    1) Rash, swelling, itching, irritation, and other abnormal reactions on the skin after using the product.
    2) When the abnormalities above appear on the skin due to direct sunlight, etc.
    B. Do NOT use on a scar, or skin affected by dermatitis, eczema, etc.
    C. Notes for Storage
    1) Make sure to close the lid after use.
    2) Keep away from babies and children.
    3) Do not store in high/low temperature or under direct sun light.
    Abnormal products will be compensated for according to “Standard for Consumer Dispute Resolution” by Fair Trade Commission


  • DOSAGE & ADMINISTRATION

    for topical use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    CORAL S 
    glycerin soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61254-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT (UNII: 3RT3536DHY)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61254-2001-1100 g in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/02/2014
    Labeler - Happy Sonic Global Co., Ltd. (688735115)
    Registrant - Happy Sonic Global Co., Ltd. (688735115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Happy Sonic Global Co., Ltd.688735115manufacture(61254-2001)
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