Label: ECODERM- 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 January 16, 2011

If you are a consumer or patient please visit this version.

  • DRUG FACTS

    Drug Facts
    Active Ingredient                             Purpose
    Colloidal Oatmeal (0.1%)                 Skin Protectant
    Aka Avena sativa (0.1%)                 Skin Protectant
    ________________________________________
    Uses 
    n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.
    ________________________________________
    Warnings
    n For external use only   
    n Keep away from children   
    n Avoid contact with eyes  
    n May be harmful if swallowed or inhaled
    ________________________________________
    Ask a physician
    n If symptoms last for more than 7 days or clear up and recur within a few days.
    n If the conditions do not improve.  
    n Before use on children under 2 years.
    n Before use if you are allergic to any ingredients listed on this label.
    ________________________________________
    Directions
    Apply to affected skin area and rub gently.  Repeat the process as needed.
    ________________________________________
    Other information   
    This is an OTC skin protectant drug product for human use.  Store at 40 to 100 degrees F.  Net contents:  3 mL (dropper bottle).  This product contains no alcohol; no animal products.              
    ________________________________________
    Inactive ingredients  
    Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid. 
    ________________________________________
    Questions and Side effects
    Use of this product results in no known side effects when used according to directions.  Phillips Company, 311 Chickasaw Street, Millerton, OK USA 74750;    Tel.  580-746-2430  
    Email address:  hp@valliant.net
  • ACTIVE INGREDIENTS

    Colloidal Oatmeal (0.1%)                 Skin Protectant
    Aka Avena sativa (0.1%)                 Skin Protectant
  • ASK DOCTOR


    Ask a doctor
    n If symptoms last for more than 7 days or clear up and recur within a few days.
    n If the conditions do not improve.  
    n Before use on children under 2 years.
    n Before use if you are allergic to any ingredients listed on this label.
  • DO NOT USE

    n Avoid contact with eyes  
    n May be harmful if swallowed or inhaled
  • CHILDREN

     
    Keep away from children   
    Avoid contact with eyes  
    May be harmful if swallowed or inhaled

  • PURPOSE


    n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.
  • STOP USE

    n For external use only   
    n Keep away from children   
    n Avoid contact with eyes  
    n May be harmful if swallowed or inhaled
    ________________________________________
    Ask a physician
    n If symptoms last for more than 7 days or clear up and recur within a few days.
    n If the conditions do not improve.  
    n Before use on children under 2 years.
    n Before use if you are allergic to any ingredients listed on this label.
  • WHEN USING

    Apply to affected skin area and rub gently.  Repeat the process as needed.
    Store at 40 to 100 degrees F.

    n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.
    n For external use only   
    n Keep away from children   
    n Avoid contact with eyes  
    n May be harmful if swallowed or inhaled

    Ask a physician If symptoms last for more than 7 days or clear up and recur within a few days.

  • WARNINGS

    n For external use only   
    n Keep away from children   
    n Avoid contact with eyes  
    n May be harmful if swallowed or inhaled

  • DOSAGE & ADMINISTRATION

    Apply to affected skin area and rub gently.  Repeat the process as needed.

  • USE

    Uses 
    n Temporarily protects and helps relieve minor skin irritation and itching due to eczema.

    Directions
    Apply to affected skin area and rub gently.  Repeat the process as needed.

  • INACTIVE INGREDIENTS

    Inactive ingredients  
    Water, dimethyl sulfoxide, dipropylene glycol, ascorbic acid, sorbic acid, magnesium stearate, stearic acid. 
  • Image of product

    Image of product
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  • INGREDIENTS AND APPEARANCE
    ECODERM 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43074-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.001 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    dimethyl sulfoxide (UNII: YOW8V9698H)  
    ascorbic acid (UNII: PQ6CK8PD0R)  
    dipropylene glycol (UNII: E107L85C40)  
    water (UNII: 059QF0KO0R)  
    sorbic acid (UNII: X045WJ989B)  
    magnesium stearate (UNII: 70097M6I30)  
    stearic acid (UNII: 4ELV7Z65AP)  
    sodium dodecylbenzenesulfonate (UNII: 554127163Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43074-113-241 in 1 BOX
    1NDC:43074-113-233 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/30/2010
    Labeler - Phillips Company (612368238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Phillips Company612368238manufacture