Label: ECZEMA 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 September 25, 2023

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  • ACTIVE INGREDIENTS

    Colloidal Oatmeal 1.00%

  • PURPOSE

    SKIN PROTECTANT

  • USES

    • temporarily protects and helps relieve minor skin irritation and itching due to:
    • rashes
    • eczema
    • poison ivy, oak, or sumac
    • insect bites
  • WARNINGS

    • do not get into eyes.
    • to avoid slipping, use mat in tub or shower.
    • in some skin conditions, soaking too long may over dry.

  • 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
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help, or contact a Poison Control Center right away.

  • PREGNANCY

    IF PREGNANT OR BREAST-FEEDING, ask a health professional before use

  • DIRECTIONS

    • apply as needed
  • INACTIVE INGREDIENTS

    Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Bisabalol, Beeswax, Butyrospermum Parkii (Shea) Butter, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oil, Ceramide NG, Chamomilla Matricaria (Chamomile) Extract, Cucumis Sativus (Cucumber) Extract, Emu Oil, Glucosamine Sulfate, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus
    (Sunflower) Oil, Punica Granatum (Pomegranate) Extract, Xanthan Gum.

  • OTHER INFORMATION

    Protect the product in this container from excessive heat and direct sun.

  • QUESTIONS?

    (917) 745-3082

  • PRINCIPAL DISPLAY PANEL

    01b LBL_EczemaCreamLabel

  • INGREDIENTS AND APPEARANCE
    ECZEMA RELIEF 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80551-301
    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
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CUCUMBER (UNII: YY7C30VXJT)  
    EMU OIL (UNII: 344821WD61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    LICORICE (UNII: 61ZBX54883)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    CERAMIDE NG (UNII: C04977SRJ5)  
    CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80551-301-3496 g in 1 TUBE; Type 0: Not a Combination Product10/03/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34710/03/2021
    Labeler - ACUTENS, INC. (051133165)
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