ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT (OATMEAL) LOTION [ZO SKIN HEALTH, INC.]

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ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT (OATMEAL) LOTION [ZO SKIN HEALTH, INC.]
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NDC 42851-080-12
Set ID 376f2589-d8da-4278-a46b-3e4778bee035
Category HUMAN OTC DRUG LABEL
Packager ZO Skin Health, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Colloidal Oatmeal, 1%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to:

    • rashes.
  • Warnings

    For external use only

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of the reach of children

  • Directions

    apply as needed

  • Inactive ingredients

    Water, Isopropyl Isostearate, Glycerin, Petrolatum, Dimethicone, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Beta-Glucan, PEG-100 Stearate, Glyceryl Stearate, Steareth-21, Polymethyl Methacrylate, Benzyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzalkonium Chloride, Aminomethyl Propanol, Butylene Glycol, Myristoyl Pentapeptide-11, Tocopheryl Acetate, Tetrapeptide-21, Retinyl Palmitate, Ascorbic Acid.

  • SPL UNCLASSIFIED SECTION

    DIST BY
    ZO Skin Health, Inc.
    Irvine, CA 92618

  • PRINCIPAL DISPLAY PANEL - 120 mL Tube Label

    ZO®MEDICAL
    BY ZEIN OBAGI, MD

    NDC 42851-080-12

    REGENACELL™
    Epidermal Repair Crème

    Skin Protectant

    120 mL / 4.0 Fl.Oz.

    PRINCIPAL DISPLAY PANEL - 120 mL Tube Label
  • INGREDIENTS AND APPEARANCE
    ZO MEDICAL REGENACELL EPIDERMAL REPAIR CREME SKIN PROTECTANT 
    oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SHEANUT OIL (UNII: O88E196QRF)  
    CURDLAN (UNII: 6930DL209R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARETH-21 (UNII: 53J3F32P58)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRAPEPTIDE-21 (UNII: 179JUC43HU)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42851-080-12120 mL in 1 TUBE; Type 0: Not a Combination Product11/14/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34711/14/2014
    Labeler - ZO Skin Health, Inc. (826468527)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab790530976MANUFACTURE(42851-080)
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