MG217 BABY ECZEMA- colloidal oatmeal lotion 
Wisconsin Pharmacal Company

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.

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Active Ingredient

Colloidal Oatmeal (Oat Kernel Flour) 2%

Purpose

Skin Protectant

Uses

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

For external use only

When using this product Do not get into eyes

Stop using and ask doctor if:

Keep out of reach of children

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

Directions

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

Other Information

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

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 or comments?

1-800-635-3696

Tube Label

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)

Revised: 11/2017
Document Id: 5f0d0717-3ece-3aa7-e053-2991aa0a256e
Set id: 5d65052d-2972-544d-e053-2a91aa0afa3e
Version: 2
Effective Time: 20171128
 
Wisconsin Pharmacal Company