Label: OKEEFFES ECZEMA RELIEF HAND CREAM- colloidal oatmeal cream
- NDC Code(s): 71564-003-02
- Packager: The Gorilla Glue Company/O'Keeffe's 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 January 1, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
-
INACTIVE INGREDIENT
Inactive ingredients Water, Glycerin, Cetyl Alcohol, Isopropyl Myristate, Dimethicone, Aluminum Starch Octylsuccinate, Cetearyl Alcohol, Ceteareth-20, Polysilicone-11, Butyrospermum Parkii (Shea) Butter, Distearyldimonium Chloride, Panthenol, Allantoin, 1,2-Hexanediol, Caprylyl Glycol, Polyquaternium-10, Beeswax, Caesalpinia Spinosa Gum, Bisabolol, Disodium EDTA, Zingiber Officianale (Ginger) Root Extract, Glyceryl Stearate, PEG-100 Stearate, Laureth-4, Laureth-23, Laureth-12, Phenoxyethanol, Ethylhexyglycerin
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
OKEEFFES ECZEMA RELIEF HAND CREAM
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71564-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 2 g in 100 g Inactive Ingredients Ingredient Name Strength CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK) LEVOMENOL (UNII: 24WE03BX2T) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-4 (UNII: 6HQ855798J) CAPRYLYL GLYCOL (UNII: 00YIU5438U) LAURETH-12 (UNII: OAH19558U1) YELLOW WAX (UNII: 2ZA36H0S2V) PEG-100 STEARATE (UNII: YD01N1999R) LAURETH-23 (UNII: N72LMW566G) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) EDETATE DISODIUM (UNII: 7FLD91C86K) GINGER (UNII: C5529G5JPQ) SHEA BUTTER (UNII: K49155WL9Y) ALLANTOIN (UNII: 344S277G0Z) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) CETYL ALCOHOL (UNII: 936JST6JCN) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) DIMETHICONE (UNII: 92RU3N3Y1O) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X) PANTHENOL (UNII: WV9CM0O67Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71564-003-02 57 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/01/2020 Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)