Label: MG217 BABY ECZEMA- colloidal oatmeal lotion

  • NDC Code(s): 68093-5105-1
  • Packager: Wisconsin Pharmacal Company
  • 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 November 28, 2017

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient

    Colloidal Oatmeal (Oat Kernel Flour) 2%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

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

    • eczema
    • rash
    • dermatitis
  • WARNINGS

    For external use only

  • WHEN USING

    When using this product Do not get into eyes

  • ASK DOCTOR

    Stop using and ask doctor if:

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again wtihin a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed, especially after bathing. Massage thoroughly into skin as colloidal oatmeal is slow to absorb.

  • OTHER SAFETY INFORMATION

    Other Information

    Keep cap tightly closed when not in use. Store at room temperature.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Purified Water, Cetyl Alcohol, Glycerin, Cetearyl Alcohol, Dicetylphosphate, Ceteth-10 Phosphate, Isopropyl Myristate, Persea Gratissima (Avocado) Oil, Glucono Delta Lactone, Glyceryl Monolaurate, D-Panthenol, Xanthan Gum, Hydroxypropyl Bispalmitamide MEA, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Palmitic Acid, Conjugated Linoleic Acid, Cholesterol, Euphorbia Cerifera (Candelilla) Wax, Phenoxyethanol, Ethylhexyl Glycerin, Allantoin, Glycyrrhizic Acid, Sodium Benzoate, Sodium Hydroxide, Menthol, Disodium EDTA

  • QUESTIONS

    Questions or comments?

    1-800-635-3696

  • PRINCIPAL DISPLAY PANEL

    Tube Label

  • INGREDIENTS AND APPEARANCE
    MG217 BABY ECZEMA 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68093-5105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.02 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALLANTOIN (UNII: 344S277G0Z)  
    GLYCYRRHIZIN (UNII: 6FO62043WK)  
    GLYCERYL 1-LAURATE (UNII: WR963Y5QYW)  
    HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    MENTHOL, (+)- (UNII: C6B1OE8P3W)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    CONJUGATED LINOLEIC ACID (UNII: G199I91G4B)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68093-5105-1170 g in 1 TUBE; Type 0: Not a Combination Product02/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2016
    Labeler - Wisconsin Pharmacal Company (800873986)
    Establishment
    NameAddressID/FEIBusiness Operations
    Wisconsin Pharmacal Company800873986manufacture(68093-5105)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!