ECZEMA CARE MOISTURIZING 3 OZ. (COLLOIDAL OATMEAL) LOTION [CHINA NINGBO SHANGGE TECHNOLOGY CO., LTD.]

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ECZEMA CARE MOISTURIZING 3 OZ. (COLLOIDAL OATMEAL) LOTION [CHINA NINGBO SHANGGE TECHNOLOGY CO., LTD.]
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NDC 58503-119-01
Set ID 8397d64d-3d18-78bb-e053-2991aa0a0348
Category HUMAN OTC DRUG LABEL
Packager China Ningbo Shangge Technology Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART347
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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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