Label: OXY STEM M SERUM- dimethicone 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 March 22, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: DIMETHICONE 2.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: AQUA (WATER), Propylene Glycol, Glycerin, PEG-7 Glyceryl Cocoate, Water (aqua), Pentylene Glycol, Tocopheryl Acetate, Hydrolyzed Pea, PEG-40 Hydrogenated Castor Oil, Trideceth-9, Glycerin, Retinyl Palmitate, Carbomer, Triethanolamine, Fructose, Urea, Citric Acid, Phenoxyethanol, Ethylhexylglycerin, Sodium Hydroxide, Glycoproteins, Glutamic Acid, Valine, Threonine, Maltose, Sodium PCA, Sodium Chloride, Sodium Lactate, Trehalose, Allantoin, Sodium Hyaluronate, Glucose

  • PURPOSE

    Purpose: Anti-fatigue and lifting Serum

  • WARNINGS

    Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: Apply morning and night

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Apply morning and night on clean face and neck prior to moisturizer

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    OXY STEM M SERUM 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71276-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.0 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71276-070-021 in 1 CARTON03/02/2017
    1NDC:71276-070-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/02/2017
    Labeler - ULAB (688976692)
    Registrant - ULAB (688976692)
    Establishment
    NameAddressID/FEIBusiness Operations
    ULAB688976692relabel(71276-070)
    Establishment
    NameAddressID/FEIBusiness Operations
    U-LAB Switzerland AG485958743manufacture(71276-070)
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