Label: RESURFACE MASK- glycerin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 22, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: GLYCERIN 6.83%

  • INACTIVE INGREDIENT

    Inactive ingredients: AQUA (WATER), LACTIC ACID, BUTYLENE GLYCOL, GLYCOLIC ACID, SODIUM HYDROXIDE, DEHYDROXANTHAN GUM, ORYZA SATIVA (RICE) POWDER, POLYETHYLENE, SODIUM BENZOATE, PHENOXYETHANOL, PPG-26-BUTETH-26, PEG-40 HYDROGENATED CASTOR OIL, PARFUM (FRAGRANCE), DISODIUM EDTA, PROPYLENE GLYCOL, BACILLUS FERMENT, POTASSIUM SORBATE

  • PURPOSE

    Purpose: Skin exfoliating gel mask

  • WARNINGS

    Warnings: For external use only Avoid contact with eyes and eye contour area Discontinue use if signs of irritation or rashes appear. In case of contact with eyes, rinse immediately.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: Use up to twice a month for a soft peeling or once a month for a strong peeling

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Leave on for 5 - 10 minutes then rub with water on fingertips before rinse with lukewarm water or soaked sponge

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    RESURFACE MASK 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.04 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71276-150-021 in 1 CARTON03/02/2017
    1NDC:71276-150-0130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/02/2017
    Labeler - ULAB (688976692)
    Registrant - ULAB (688976692)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULAB688976692relabel(71276-150)
    Establishment
    NameAddressID/FEIBusiness Operations
    U-LAB Switzerland AG485958743manufacture(71276-150)
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