Label: ALOE PROPOLIS SOOTHING 30ML- allantoin gel

  • NDC Code(s): 69998-140-01, 69998-140-02
  • Packager: BENTON KOREA
  • 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 19, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.50%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Aloe Barbadensis Leaf Juice, Propolis Extract, Glycerin, Pentylene Glycol, Zanthoxylum Piperitum Fruit Extract, Pulsatilla Koreana Extract, Usnea Barbata (Lichen) Extract, Betaine, Arginine, Cucumis Sativus (Cucumber) Fruit Extract, Portulaca Oleracea Extract, Citrus Limon (Lemon) Fruit Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Acrylates/C10-30 Alkyl Acrylate Crosspolymer

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: 1. In case of having following symptoms after using this, you’re advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist. 1) In case of having problems such as red rash, swollenness, itching, stimulation during usage. 2) In case of having the same symptoms above on the part you put this product on by direct sunlight. 2. You are banned to use it on the part where you have a scar, eczema, or dermatitis. 3. In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: Keep out of reach of babies and children.

  • INDICATIONS & USAGE

    Indications & Usage: After washing the face, put the skin toner and essence, and then take 1-2g into your palm and evenly apply to the entire face. Please slightly tap to enhance the absorption.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ALOE PROPOLIS SOOTHING 30ML 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69998-140
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.15 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69998-140-021 in 1 CARTON09/01/2016
    1NDC:69998-140-0130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2016
    Labeler - BENTON KOREA (689514965)
    Registrant - BENTON KOREA (689514965)
    Establishment
    NameAddressID/FEIBusiness Operations
    BENTON KOREA689514965repack(69998-140)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ezekiel Cosmetics Co.689061889manufacture(69998-140)