Label: ECZEMA CARE- 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 September 5, 2017

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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.
  • Warnings

    For external use only.

    When using this product

    • avoid contact with eyes.
    • if contact occurs, rinse thoroughly 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

    • for mild to moderate eczema only, apply as needed or as directed by a physician.
  • Other information

    • store at room temperature.
  • Inactive ingredients

    Water (Aqua), Glycerin, Distearyldimonium Chloride, Panthenol, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Dimethicone, Avena Sativa (Oat) Kernel Oil, Steareth-20, Avena Sativa (Oat) Kernel Extract, Benzalkonium Chloride, Isocetyl Alcohol, Ceramide NP, Sodium Chloride.

  • Label copy

    Image of the description

  • INGREDIENTS AND APPEARANCE
    ECZEMA CARE 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-355
    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 PALMITATE (UNII: 8CRQ2TH63M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    OAT (UNII: Z6J799EAJK)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ISOCETYL ALCOHOL (UNII: 1800H64066)  
    CERAMIDE NP (UNII: 4370DF050B)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-355-07216 mL in 1 TUBE; Type 0: Not a Combination Product08/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/28/2017
    Labeler - CVS Pharmacy (062312574)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(59779-355)
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