Label: DR PORE TIGHTENING GLACIAL CLAY FACIAL MASK- kaolin 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 December 7, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Kaolin 8.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Avena Sativa (Oat) Kernel Flour, Bentonite, Glycerin, Canadian Colloidal Clay, Stearic Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Portulaca Oleracea Extract, Pentylene Glycol, Triethanolamine, Glyceryl Stearate SE, Cetyl Ethylhexanoate, Magnesium Aluminum Silicate, Butylene Glycol, Saccharide Isomerate, Allantoin, Cetearyl Alcohol, Xanthan Gum, Disodium EDTA, Methylparaben, Phenoxyethanol, Propylparaben, Titanium Dioxide (CI 77891), Chromium Oxide Greens (CI 77288)

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

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

  • QUESTIONS

    Questions:

    Tel: +82-70-5066-5990

    Web: www.skinnlab.com

  • Uses

    Uses: Apply enough amount of the mask avoiding direct eye area after cleasning. After 10~15 minutes, rinse it off gently with warm water.

  • Directions

    Directions: Apply enough amount of the clay mask over your face after toning. Avoid direct eye areas. Leave it for 10-15 minutes to dry. Rinse it off with clean water, followed by thorough toning & moisturizing. Can be also used partially on problematic areas to control excess sebum secretion.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR PORE TIGHTENING GLACIAL CLAY FACIAL MASK 
    kaolin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69457-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Kaolin (UNII: 24H4NWX5CO) (KAOLIN - UNII:24H4NWX5CO) Kaolin8.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69457-050-021 in 1 CARTON11/01/2017
    1NDC:69457-050-01100 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/01/2017
    Labeler - LAB & Company Inc. (688284779)
    Registrant - LAB & Company Inc. (688284779)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(69457-050)
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