Label: ECZEMA HAND RELIEF- colloidal oatmeal cream

  • 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 August 22, 2023

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  • ACTIVE INGREDIENT

    Colloidal Oatmeal 1%

  • USES

    Temporarily protects and helps relieve minor skin irritations and itching due to rashes or eczema.

  • PURPOSE

    Skin protectant

  • WARNINGS

    For external use only.

    When using this product avoid contact with eyes. if contact occurs, rinse thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed get medical help or contact a poison control center right away.

  • STOP USE AND ASK A DOCTOR IF

    condition worsens
    symptoms last more than 7 days or clear up and occur again within a few days

  • DIRECTIONS

    Apply as needed to hands.

  • INACTIVE INGREDIENTS

    Water/Eau/Aqua, Vegetable Oil/Huile Végétale, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Butyrospermum Parkii (Shea) Butter, Polyglyceryl-2 Stearate, Stearyl Alcohol, Glyceryl Stearate, Caprylic/Capric Triglyceride, Caprylyl Caprylate/Caprate, Jojoba Oil/Macadamia Seed Oil Esters, Annona Cherimola Fruit Extract, Helianthus Annuus (Sunflower) Seed Wax, Oryza Sativa (Rice) Bran Extract, Cocos Nucifera (Coconut) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalene, Helianthus Annuus (Sunflower) Extract, Allantoin, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Phytosteryl Macadamiate, Amylopectin, Phytosterols, Lecithin, Acetyl Glutamine, Lithothamnion Calcareum Extract, Folic Acid, Bacillus/Soybean Ferment Extract, Oligopeptide-3, Sodium Hyaluronate, Oligopeptide-2, Oligopeptide-1, Hexapeptide-11, Lactic Acid, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Ceramide EOP, Xanthan Gum, Potassium Sorbate, Trisodium Ethylenediamine Disuccinate, Citric Acid, Ethylhexylglycerin, Sodium Citrate, Propanediol, Pentylene Glycol, Phenylpropanol, Sodium Dehydroacetate, Caprylyl Glycol, Sodium Lauroyl Lactylate, Sodium Benzoate, Carbomer, Phenoxyethanol

  • QUESTIONS?

    1.866.927.2783

  • PRINCIPAL DISPLAY PANEL

  • PRINCIPAL DISPLAY PANEL

    package label

  • INGREDIENTS AND APPEARANCE
    ECZEMA HAND RELIEF 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61328-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    AMYLOPECTIN, UNSPECIFIED SOURCE (UNII: 4XO4QFV777)  
    CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)  
    RICE GERM (UNII: 7N2B70SFEZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    MACADAMIA SEED OIL GLYCERETH-8 ESTERS (UNII: C6734SM77O)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    ACEGLUTAMIDE (UNII: 01J18G9G97)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    HEXAPEPTIDE-11 (UNII: NCJ63WU6BY)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CHERIMOYA (UNII: 33WVT714QS)  
    SUNFLOWER SEED (UNII: R9N3379M4Z)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ROSEMARY (UNII: IJ67X351P9)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    FOLIC ACID (UNII: 935E97BOY8)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SQUALENE (UNII: 7QWM220FJH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61328-010-0090 g in 1 TUBE; Type 0: Not a Combination Product10/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/01/2023
    Labeler - Skinfix, Inc. (203158183)
    Registrant - Skinfix, Inc. (203158183)
    Establishment
    NameAddressID/FEIBusiness Operations
    SIGAN INDUSTRIES INC255106239manufacture(61328-010)
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