ECODERM (COLLOIDAL OATMEAL) LOTION [PHILLIPS COMPANY]

ECODERM (COLLOIDAL OATMEAL) LOTION [PHILLIPS COMPANY]
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NDC 43074-113-23, 43074-113-24
Set ID 64c67e81-dbfb-4e8a-b3ae-13ab360673ad
Category HUMAN OTC DRUG LABEL
Packager Phillips Company
Generic Name
Product Class
Product Number
Application Number PART347
  • 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
    Image of product


  • 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

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