Label: ECZEMA- 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 April 5, 2016

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

  • ACTIVE INGREDIENT

    Active Ingredient                              Purpose

    Colloidal Oatmeal 2.5% ............. Skin Protectant

  • PURPOSE

    Uses

    Protects and helps relieve eczema (Atopic Dermatitis)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • INDICATIONS & USAGE

    Eczema Cream

    Skin Protectant with Colloidal Oatmeal

    MooGoo

    For Symptomatic Relief of Eczema (Atopic Dermatitis)

    Finally, an alternative!

    Eczema is very common in children and some adults. Our website has more information on how to manage this condition.

    MooGoo products originate from a cream used in australian dairy farms to repair the skin on cow's udders! This cream was full of natural skin healing ingredients, and no gimmicks. All MooGoo products are made this way.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed to affected area. For use on mild to moderate eczema or as directed by a physician.

  • WARNINGS

    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
  • INACTIVE INGREDIENT

    Inactive Ingredients

    aqua, prunus amygdalus dulcis (sweet almond) oil, emulsifying wax NF, olea europaea (olive) fruit oil, cetearyl alcohol, squalane, avena sativa (oatmeal) kernel flour, aloe barbadensis leaf juice (aloe vera), polysorbate 60, chamomilla recutita (matricaria) flower extract (chamomile), centella asiatica leaf extract, piroctone olamine, allantoin, tocopherol (natural vitamin E), xanthan gum (food grade thickener), glyceryl caprylate, sodium phytate, humulus lupulus (hops) extract.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    ECZEMA 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69788-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PEG-150 STEARATE (UNII: 7BSG7DF10Q)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SQUALANE (UNII: GW89575KF9)  
    AVENA SATIVA TOP (UNII: 1ZX4OXU3N6)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CENTELLA ASIATICA LEAF (UNII: 6810070TYD)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    ALLANTOIN (UNII: 344S277G0Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL CAPRYLATE (UNII: MCF579Z59B)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    HUMULUS LUPULUS WHOLE (UNII: 912A6Q1N4A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69788-001-01100 g in 1 PACKAGE; Type 0: Not a Combination Product04/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/05/2016
    Labeler - MooGoo USA LLC (076343899)
    Establishment
    NameAddressID/FEIBusiness Operations
    MooGoo USA LLC076343899manufacture(69788-001)