Label: 75% OLIVE OIL MARSEILLE- glycerin soap

  • 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 April 20, 2016

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  • ACTIVE INGREDIENT

    glycerine


  • INACTIVE INGREDIENT

    coconut oil, palm oil, olive oil, sodium hydroxide, water, etc

  • PURPOSE

    skin protectant


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    apply to the skin and wash away


  • WARNINGS

    ・Stop using the product when you have skin problems or the product disagrees with your skin
    ・Stop using the product immediately and consult a dermatologist if you have redness, swelling, itching or irritation on the skin while or after using the product.
    ・If the product gets into the eyes, don't rub but rinse with water.
    ・Don't place the product in any place where it will be subjected to extremely high or low temperatures or direct sunlight.


  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    75% OLIVE OIL MARSEILLE 
    glycerin soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69836-4001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69836-4001-1100 g in 1 PACKAGE; Type 0: Not a Combination Product04/19/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/17/2015
    Labeler - International Nature Soap Institute (689513512)
    Registrant - International Nature Soap Institute (689513512)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Nature Soap Institute689513512manufacture(69836-4001)
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