Label: ECZEMA CARE MOISTURIZING 3 OZ.- 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 March 8, 2019

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  • Active ingredient

    Colloidal Oatmeal 1%

    Purpose

    Skin protectant

  • Uses

    • Temporarily protects and helps relieve minor skin itching and irritation due to:
    • Eczema
    • Rashes
  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes. In case of eye contact, flush with water.

    Stop using this product and ask a doctor if

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

    Keep out of reach of children.

    • In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.
  • Directions

    Apply as needed

  • Other information

    • store at room temperature.
  • Inactive ingredients

    Water, Glycerin, Petrolatum, Cetearyl Alcohol, Dimethicone, Isopropyl Myristate, Distearyldimonium Chloride, Steareth-2, Avena Sativa (Oat) Kernel Extract, Phenoxyethanol, Steareth-21, Sodium Chloride, Benzalkonium Chloride, Panthenol, Ceramide NP, Avena Sativa (Oat) Kernel Oil

  • Label copy

    label

  • INGREDIENTS AND APPEARANCE
    ECZEMA CARE MOISTURIZING  3 OZ.
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-119
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    OAT (UNII: Z6J799EAJK)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-119-0185 mL in 1 TUBE; Type 0: Not a Combination Product03/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/08/2019
    Labeler - China Ningbo Shangge Technology Co., Ltd. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Technology Co., Ltd.529287434manufacture(58503-119)
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