Label: GLAD SKIN ECZEMA CREAM- colloidal oatmeal lotion

  • 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 April 21, 2022

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  • Active Ingredient

    Colloidal Oatmeal 0.02%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin iritation and itching due to eczema.

  • Warnings

    For external use only.

    When using this product do not get into eyes.

    Stop use and ask a doctor if:

    • Conditions worsen
    • Symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away. ​

  • Directions

    • Apply twice daily, or more as desired, on skin free of other products.
    • Let the cream absorb into skin for 5 minutes before applying other products.
  • Inactive Ingredients

    Water, Glycerin, Petrolatum, Mineral Oil, Cetearyl Alcohol, Ceteareth-20, Arginine HCl, Sodium Chloride, Trometamol, Calcium Chloride, sr-(Methionyl Staphylococcus Simulans Polypeptide-1 Dipeptide-53 Staphylococcus Phage 2638A Polypeptide-1)​

    Questions

    hello@gladskin.com

  • Principle Display Label - Gladskin Eczema Cream 50 mL

    Principle Display Label

  • INGREDIENTS AND APPEARANCE
    GLAD SKIN  ECZEMA CREAM
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0548
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.175 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Colorwhite (Off White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58443-0548-350 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/06/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/06/2019
    Labeler - Prime Enterprises (101946028)
    Registrant - Prime Enterprises (101946028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprise101946028pack(58443-0548) , manufacture(58443-0548) , analysis(58443-0548) , label(58443-0548)
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