Label: 75% OLIVE OIL MARSEILLE- glycerin soap

  • NDC Code(s): 69836-4001-1
  • Packager: International Nature Soap Institute
  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    glycerine


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  • INACTIVE INGREDIENT

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

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  • PURPOSE

    skin protectant


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  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

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  • INDICATIONS & USAGE

    apply to the skin and wash away


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  • 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.


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  • DOSAGE & ADMINISTRATION

    for external use only

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  • INGREDIENTS AND APPEARANCE
    75% OLIVE OIL MARSEILLE 
    glycerin soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69836-4001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69836-4001-1 100 g in 1 PACKAGE; Type 0: Not a Combination Product 04/19/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part347 06/17/2015
    Labeler - International Nature Soap Institute (689513512)
    Registrant - International Nature Soap Institute (689513512)
    Establishment
    Name Address ID/FEI Business Operations
    International Nature Soap Institute 689513512 manufacture(69836-4001)
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