Label: CHILDS FARM ECZEMA MOISTURIZING CREAM- colloidal 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 February 28, 2023

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  • Drug Facts

  • Active Ingredient

    Colloidal Oatmeal 1.5%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to:

    • Rashes
    • Eczema
  • Warnings

    For external use only.

    When using this product

    • do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Centre right away.

  • Directions

    Apply as needed

  • Other information

    Store at room temperature

  • Inactive ingredients

    Aqua (Water), Glycerin, Isopropyl Myristate, Glyceryl Stearate, Cetearyl Alcohol, Cetearyl Isononanoate, Butyrospermum Parkii (Shea) Butter, Tapioca Starch, Benzyl Alcohol, Sodium Cetearyl Sulfate, Avena Sativa (Oat) Kernel Oil, Dehydroacetic Acid, Citric Acid, Sodium Hydroxide

  • Questions?

    TOLL FREE: 888 565 0730

    www.childsfarm.com

  • Company Information

    Manufactured for:

    Childs Farm Inc.,

    70 W Madison Street, Ste. 5750

    Chicago, IL 60602 USA

  • Product Packaging

    eczema

  • INGREDIENTS AND APPEARANCE
    CHILDS FARM ECZEMA MOISTURIZING CREAM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83244-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83244-001-01250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01604/01/2023
    Labeler - Childs Farm, Inc. (118769915)
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