Label: ECZEMA DERMATITIS RELIEF BALM- colloidal oatmeal cream
- NDC Code(s): 61328-112-20
- Packager: Skinfix, Inc.
- 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 May 12, 2023
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- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- STOP USE AND ASK A DOCTOR IF
- DIRECTIONS
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INACTIVE INGREDIENTS
Water/Aqua/Eau, Glycerin, Annona Cherimola Fruit Extract, Jojoba Oil/Macadamia Seed Oil Esters, Cetearyl Alcohol, Glyceryl Stearate, Cetearyl Olivate, Coco-Caprylate/Caprate, Sorbitan Olivate, Squalane, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Octyldodecanol, Triheptanoin, Allantoin, Zinc Oxide, Squalene, Helianthus Annuus (Sunflower) Seed Wax, Phytosteryl Macadamiate, Phytosterols, Lecithin, Acetyl Glutamine, Castanea Sativa (Chestnut) Leaf Extract, Ceramide NP, Amylopectin, Chlorophyllin-Copper Complex, Phytosphingosine, Ceramide AP, Cholesterol, Folic Acid, Hexapeptide-11, Oligopeptide-1, Oligopeptide-2, Bacillus/Soybean Ferment Extract, Sodium Hyaluronate, Oligopeptide-3, Tocopherol, Lithothamnion Calcareum Extract, Ceramide EOP, Carbomer, Sodium Stearoyl Glutamate, C9-12 Alkane, Polyurethane-100, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol, Caprylic/Capric Triglyceride, Sodium Lauroyl Lactylate, Sodium Hydroxide, Sodium Citrate, Propanediol, Polyhydroxystearic Acid, Pentylene Glycol, Sodium Dehydroacetate, Phenylpropanol, Citric Acid, Xanthan Gum, Lactic Acid, Sodium Carbonate, Sodium Chloride, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol.
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INGREDIENTS AND APPEARANCE
ECZEMA DERMATITIS RELIEF BALM
colloidal oatmeal creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61328-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL 5 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777) PHENYLPROPANOL (UNII: 0F897O3O4M) PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CARBONATE (UNII: 45P3261C7T) SODIUM BENZOATE (UNII: OJ245FE5EU) MACADAMIA SEED OIL GLYCERETH-8 ESTERS (UNII: C6734SM77O) HEXYLENE GLYCOL (UNII: KEH0A3F75J) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SHEA BUTTER (UNII: K49155WL9Y) HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TOCOPHEROL (UNII: R0ZB2556P8) PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H) SORBITAN OLIVATE (UNII: MDL271E3GR) OCTYLDODECANOL (UNII: 461N1O614Y) SQUALANE (UNII: GW89575KF9) SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024) ZINC OXIDE (UNII: SOI2LOH54Z) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SODIUM HYDROXIDE (UNII: 55X04QC32I) PROPANEDIOL (UNII: 5965N8W85T) CASTANEA SATIVA LEAF (UNII: IV3S2HH53G) SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) HEXAPEPTIDE-11 (UNII: NCJ63WU6BY) LACTIC ACID (UNII: 33X04XA5AT) CERAMIDE 1 (UNII: 5THT33P7X7) WATER (UNII: 059QF0KO0R) TRIHEPTANOIN (UNII: 2P6O7CFW5K) ALLANTOIN (UNII: 344S277G0Z) SQUALENE (UNII: 7QWM220FJH) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CHOLESTEROL (UNII: 97C5T2UQ7J) XANTHAN GUM (UNII: TTV12P4NEE) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) CETEARYL OLIVATE (UNII: 58B69Q84JO) SUNFLOWER OIL (UNII: 3W1JG795YI) PHENOXYETHANOL (UNII: HIE492ZZ3T) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) ACEGLUTAMIDE (UNII: 01J18G9G97) CERAMIDE NP (UNII: 4370DF050B) CERAMIDE AP (UNII: F1X8L2B00J) FOLIC ACID (UNII: 935E97BOY8) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CHERIMOYA (UNII: 33WVT714QS) Product Characteristics Color green Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61328-112-20 50 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M016 10/01/2023 Labeler - Skinfix, Inc. (203158183) Registrant - Skinfix, Inc. (203158183) Establishment Name Address ID/FEI Business Operations SIGAN INDUSTRIES INC 255106239 manufacture(61328-112)
