Label: ECZEMA- colloidal oatmeal lotion

  • NDC Code(s): 73517-425-01, 73517-425-02
  • Packager: Amyris, 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 November 3, 2022

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  • Active Ingredients

    Colloidal Oatmeal 1%

    Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve minor skin irritation and itching due to
    • eczema
    • rashes
  • Warnings

    • For external use only

    When using this product

    • do not get into eyes

    Stop use and aks a doctor if

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

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •   Apply as needed
  • Other information

    Protect this product from excessive heat and direct sunlight

  • Inactive Ingredients

    Water, Squalane, Caprylic/Capric Triglyceride, Glycerin, Hydrogenated Sunflower Seed Oil Polyglyceryl-3
    Esters, Hydroxystearic/Linolenic/Oleic Polyglycerides, Butyrospermum Parkii (Shea ) Butter, Jojoba Esters.
    Cetearyl Alcohol, Hydrogenated Sunflower Seed Oil Glyceryl Esters, Propanediol, Hydroxyacetophenone, Sodium Stearoyl Lactylate, Xanthan
    Gum, Citric Acid, Ethylhexylglycerin, Potassium Sorbate, Ceramide NP, Sodium Phytate, Tocopherol.

  • PRINCIPAL DISPLAY PANEL

    eczemaUC

  • INGREDIENTS AND APPEARANCE
    ECZEMA 
    colloidal oatmeal lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73517-425
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER SEED OIL GLYCERETH-8 ESTERS (UNII: 358X17CAT0)  
    12-HYDROXYSTEARIC ACID (UNII: 933ANU3H2S)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HEXASODIUM PHYTATE (UNII: ZBX50UG81V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73517-425-011 in 1 CARTON02/01/2021
    1177 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:73517-425-0230 mL in 1 TUBE; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01602/01/2021
    Labeler - Amyris, Inc (185930182)
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