Label: OKEEFFES ECZEMA RELIEF BODY CREAM- colloidal oatmeal cream
- NDC Code(s): 71564-004-05, 71564-004-07, 71564-004-08
- Packager: The Gorilla Glue Company/O'Keeffe's Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
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- 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
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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
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INGREDIENTS AND APPEARANCE
OKEEFFES ECZEMA RELIEF BODY CREAM
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71564-004 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 CAPRYLYL GLYCOL (UNII: 00YIU5438U) LAURETH-12 (UNII: OAH19558U1) CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO) POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK) 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) LEVOMENOL (UNII: 24WE03BX2T) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) LAURETH-4 (UNII: 6HQ855798J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71564-004-08 227 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2020 2 NDC:71564-004-07 7 g in 1 TUBE; Type 0: Not a Combination Product 08/06/2020 3 NDC:71564-004-05 142 g in 1 TUBE; Type 0: Not a Combination Product 08/08/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 07/01/2020 Labeler - The Gorilla Glue Company/O'Keeffe's Company (004251914)