Label: ECZEMA RELIEF- colloidal oatmeal cream

  • NDC Code(s): 82960-256-01
  • Packager: Rosemont Ventures, 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 September 21, 2022

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  • Active Ingredient

    Colloidal Oatmeal 1.0%

  • Purpose

    Colloidal Oatmeal 1.0%................Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to:

    • rashes
    • eczema
  • Warnings

    For external use only

    When using this product

    • do not get into eyes

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

  • Directions

    Apply as needed

  • Inactive Ingredients

    Allantoin, Aloe Barbadensis (Aloe) Leaf Extract, Aqua (Water), Azadirachta Indica (Neem) Seed Oil, Bisabolol, Butyrospermum Parkii (Shea) Butter, Calcium Gluconate, Caprylic/Capric Triglyceride, Citric Acid, Eucalyptus Globulus (Eucalyptus) Leaf Oil, Gluconolactone, Glycerin, Glyceryl Stearate SE, Kaolin, Potassium Sorbate, Sodium Benzoate, Squalane, Stearyl Alcohol, Xanthan Gum, Zea Mays (Corn) Starch†, Zinc Oxide

  • Questions or Comments?

    Call (800) 246-7328 or visit www.allterrainco.com

  • PRINCIPAL DISPLAY PANEL

    Effective, natural & safe

    ALL TERRAIN

    Eczema Relief Cream

    Colloidal Oatmeal 1% Skin Protectant

    Soothes, protects & relieves itching & irritation due to eczema

    Made with 95+% naturally derived ingredients

    2.0 FL. OZ. (59 mL)

    1

    2

  • INGREDIENTS AND APPEARANCE
    ECZEMA RELIEF 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82960-256
    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
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    KAOLIN (UNII: 24H4NWX5CO)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SQUALANE (UNII: GW89575KF9)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82960-256-011 in 1 CARTON09/15/2022
    159 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01609/15/2022
    Labeler - Rosemont Ventures, Inc. (933509465)
    Establishment
    NameAddressID/FEIBusiness Operations
    Monarch PCM, LLC080000294manufacture(82960-256)
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