Label: DERMACED DEEP THERAPY ECZEMA- oatmeal cream

  • 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 July 13, 2017

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  • Active Ingredients:

    Colloidal Oatmeal 1.00%

  • Purpose:

    Skin Protectant

  • USES:

    Temporarily protects and helps relieve minor skin irritations due to Eczema and rashes.

  • WARNINGS:

    *For external use only.

    *When using this product keep out of eyes.

    *Stop use and consult physician if condition worsens; if symptoms last for more than seven days; or if symptoms clear up and occur again within a few days.

  • *Keep out of reach of Children

  • DIRECTIONS:

    *Apply as needed.

  • OTHER INGREDIENTS:

    Tllantoin, Aqua (Deionized Water), Beeswax, Benzyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia (Coneflower) Extract, Glyceryl Stearate, Glycyrrhiza Clabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Lanolin, Paraffin Wax, PEG-100 Stearate, Prunus Arnygdalus Dulcis (Sweet Almond) Oil, Simmonclsia Chinensis (jojoba) Oil, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethanolamine.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    DERMACED DEEP THERAPY ECZEMA 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71515-403
    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)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71515-403-041 in 1 BOX07/13/2017
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/13/2017
    Labeler - Dermaced LLC (080703517)
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