Label: BY PHARMICELL LAB BEAUCELL DUAL HYDROGEL MASK- glycerin patch

  • 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 July 9, 2013

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  • ACTIVE INGREDIENT

    Active ingredient : GLYCERIN 30%

  • INACTIVE INGREDIENT

    Inactive ingredient : WATER, HUMAN BONE MARROW STEM CELL CONDITIONED MEDIA, NIACINAMIDE, CERATONIA SILIQUA GUM, BUTYLENE GLYCOL, SODIUM HYALURONATE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, CHONDRUS CRISPUS (CARRAGEENAN), 1,2-HEXANEDIOL, PEG-60 HYDROGENATED CASTOR OIL, BETAINE, ALGIN, PHENYL TRIMETHICONE, DIPOTASSIUM GLYCYRRHIZATE, SODIUM POLYACRYLATE, METHYLPARABEN, PORTULACA OLERACEA EXTRACT, ADENOSINE, DISODIUM EDTA, POTASSIUM HYDROXIDE, FRAGRANCE, MANNAN

  • PURPOSE

    Purpose : Skin Protectant

  • WARNINGS

    Warning : Keep out of reach of children and babies. For external use only. Avoid contact with eyes. Discontinue use if signs of irritation and/or rash appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and babies.

  • INDICATIONS AND USAGE

    INDICATIONS AND USAGE:

    1. After washing your face, apply a toner to clean up your skin.

    2. Open the pouch and remove both films separating the upper and lower face.

    3. Attach the transparent film-removed surface of the mask to the skin. (Does not matter which side of mask is adhered onto skin.)

    4. Remove the mask about 20-40min later, and tap the face lightly for the skin to absorb the contents of the mask remaining on the face.

  • DOSAGE AND ADMINISTRATION

    Dosage and administration : Putting the product on the skin for 20-40 minutes, remove the mask and spread the remaining product evenly over the entire face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BY PHARMICELL LAB BEAUCELL DUAL HYDROGEL MASK 
    glycerin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60949-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN9 g  in 5 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60949-110-015 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/01/2013
    Labeler - Pharmicell Co., Ltd. (687744110)
    Registrant - Pharmicell Co., Ltd. (687744110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmicell Co., Ltd.687744110manufacture(60949-110)
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