Label: POST PEEL PROTECTANT VITALITY INSTITUTE- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 April 2, 2015

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  • ACTIVE INGREDIENT

    Active Ingredients                   Purpose

    Hydrocortisone 1% ................. Anti-itch

  • PURPOSE

    Uses

    • For the temporary relief of of itching associated with minor skin irritations and rashes due to
    • Eczema
    • insect bites
    • poison ivy, poison oak, poison sumac
    • soaps and detergents cosmetics
    • jewelry

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children. If swallowed, get medial help or contact a Poison Control Center rigth away
  • INDICATIONS & USAGE

    Stop use and ask a doctor

    if condition worsens, or if symptoms persist for more than 7 day or clear up and occur again within a few days, do not use this or any other hydrocortisone products unless you hav consulted a doctor.

  • WARNINGS

    Warnings

    • For external use only
    • Avoid Contact with eyes
  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and children under 2 years of age and older: Appyl to affected area not more than 3 to 4 times daily
    • Children under 2 years of age: Do not use, consult a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients

    

    Water (Aqua), Cyclopentasiloxane, Demthicone/Vinyl Dimethicone Crosspolymer, Aloe Barbadensis Leaf Juice, Glycerin, Cetearyl Alcohol, Ceteareth-20, Caprylic/Capric Triglyceride, Cetyl Alcohol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Avena Sativa (Oat) Kernel Extract, Chrysanthemum Pathenium (Feverfew) Extract, Tocophoneryl Acetate, Allantoint, Ethylhexylglycerin, Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    Vitality Institute

    Skin Care System

    Post Peel Protectant

    Anti-itch Cream

    30 mL/1 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    POST PEEL PROTECTANT  VITALITY INSTITUTE
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69718-154
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    OAT (UNII: Z6J799EAJK)  
    TANACETUM PARTHENIUM (UNII: 6GE7Z0761K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69718-154-021 in 1 BOX
    1NDC:69718-154-0130 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/25/2015
    Labeler - Vitality Institute Medical Products (056496844)
    Registrant - VEGE-KURL, INC (021072509)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEGE-KURL, INC021072509manufacture(69718-154)
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