Label: EVEREDEN INTENSIVE ECZEMA BALM- colloidal oatmeal ointment
- NDC Code(s): 72113-109-21
- Packager: Eden Brands Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated September 16, 2024
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- STATEMENT OF IDENTITY
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Helianthus Annuus (Sunflower) Seed Oil, C18-38 Alkyl Hydroxystearoyl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Squalane, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Polyhydroxystearic Acid, Cocos Nucifera (Coconut) Oil, Vegetable Oil, Caprylic/Capric Triglyceride, Simmondsia Chinensis (Jojoba) Butter, Octyldodecanol, Euphorbia Cerifera (Candelilla) Wax, Isostearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Spent Grain Wax, Ribes Nigrum (Black Currant) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Phaeodactylum Tricornutum Extract, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Argania Spinosa Kernel Oil, Hydrogenated Vegetable Oil, Beta-Sitosterol, Boswellia Serrata Gum, Oleic Acid, Linoleic Acid, Phytosterols, Phospholipids, Glyceryl Behenate, Saccharomyces/Zinc Ferment, Saccharomyces/Magnesium Ferment, Saccharomyces/Iron Ferment, Saccharomyces/Silicon Ferment, Saccharomyces/Copper Ferment, Polyglyceryl-4 Isostearate, Lecithin, Polyglyceryl-3 Diisostearate, Ceramide NG, Ceramide NP, Water (Aqua), Rosmarinus Officinalis (Rosemary) Leaf Extract, Quercetin, Tocopherol
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INGREDIENTS AND APPEARANCE
EVEREDEN INTENSIVE ECZEMA BALM
colloidal oatmeal ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72113-109 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 POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CANDELILLA WAX (UNII: WL0328HX19) RIBES NIGRUM SEED OIL (UNII: GKE1188837) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) OCTYLDODECANOL (UNII: 461N1O614Y) ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y) SUNFLOWER OIL UNSAPONIFIABLES (UNII: T7ZE2WA4MB) POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7) WATER (UNII: 059QF0KO0R) C18-38 ALKYL HYDROXYSTEAROYL STEARATE (UNII: WW4FVB2PEM) .BETA.-SITOSTEROL (UNII: S347WMO6M4) INDIAN FRANKINCENSE (UNII: 4PW41QCO2M) TOCOPHEROL (UNII: R0ZB2556P8) CERAMIDE NP (UNII: 4370DF050B) ROSEMARY (UNII: IJ67X351P9) SUNFLOWER OIL (UNII: 3W1JG795YI) JOJOBA OIL (UNII: 724GKU717M) SQUALANE (UNII: GW89575KF9) CARDIOSPERMUM HALICACABUM LEAF (UNII: 8W2E41J67L) CORN OIL (UNII: 8470G57WFM) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) JOJOBA BUTTER (UNII: XIA46H803R) SHEA BUTTER (UNII: K49155WL9Y) ARGAN OIL (UNII: 4V59G5UW9X) OLEIC ACID (UNII: 2UMI9U37CP) LINOLEIC ACID (UNII: 9KJL21T0QJ) OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8) CERAMIDE NG (UNII: C04977SRJ5) QUERCETIN (UNII: 9IKM0I5T1E) PHYTOSTERYL/ISOSTEARYL/CETYL/STEARYL/BEHENYL DIMER DILINOLEATE (UNII: 8N725H4EFN) COCONUT OIL (UNII: Q9L0O73W7L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72113-109-21 1 in 1 CARTON 11/18/2024 1 45 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M016 11/18/2024 Labeler - Eden Brands Inc. (081062339)
