Label: MOUNTAIN ICE ECZEMA- colloidal oatmeal cream

  • NDC Code(s): 72793-400-01, 72793-400-02
  • Packager: Mountainside Medical Equipment, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

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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

    •
    avoid contact with eyes.

    Stop use and ask a doctor if

    •
    Condition worsens.
    •
    Symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out the reach of children.

    If swallowed, seek medical attention or contact a Poison Control Center immediately.

  • Directions:

    Apply as needed. Let product rest on the skin. Avoid drying soaps that can irritate the skin. Use daily for best results.

  • Other information:

    For use on mild to moderate eczema or as directed by a physician. Store at room temperature. Avoid freezing.

  • Inactive Ingredients:

    Water (Aqua), Paraffinum Liquidum (Mineral) Oil, Stearyl Alcohol, Cetearyl Alcohol, Glycerin, Propylene Glycol, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Polysorbate 60, Actinidia Chinensis (Kiwi) Seed Oil, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Sodium Hyaluronate, Hydrolyzed Collagen, Retinyl Palmitate, Ceramide NP, Ceramide AP, Ceramide EOP, Lactic Acid, Sodium Lauroyl Lactylate, Phytosphingosine, Cholesterol, Zea Mays (Corn) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Origanum Vulgare (Oregano) Oil, Curcuma Longa (Turmeric) Root Oil, Carbomer, Xanthan Gum, Citric Acid, Ethylhexylglycerin, Disodium EDTA, Sodium Hydroxide, Phenoxyethanol, Zinc Oxide (CI 77947).

  • Package/Label Principal Display Panel – Tube Label

    MADE WITH SOLINE® AND SK-INFLUX® V MB TECHNOLOGY

    MOUNTAIN ICE
    ECZEMA CREAM

    COLLAGEN, HYALURONIC ACID, TURMERIC, KIWI SEED OIL,
    VITAMIN A, VITAMIN E, TEA TREE OIL, ZINC OXIDE, OREGANO OIL,
    SUNFLOWER OIL, COLLOIDAL OATMEAL, ALOE VERA, CERAMIDE NP,
    CERAMIDE AP, CERAMIDE EOP.


    4 fl oz (118 g)

    Questions? 1-888-687-4334
    Distributed by:
    Mountainside Medical
    9262 Old River Road
    Marcy, New York 13403
    Family Owned and Operated
    Service-Disabled Veteran

    image-01
  • Package/Label Principal Display Panel – Packet Label

    MOUNTAIN ICE
    ECZEMA CREAM
    MADE WITH SOLINE® AND SK-INFLUX® V MB TECHNOLOGY


    Net Wt. 4 grams
    www.MOUNTAIN-ICE.COM

    Distributed by:
    Mountainside Medical
    Marcy, New York 13403

    image-02
  • INGREDIENTS AND APPEARANCE
    MOUNTAIN ICE ECZEMA 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72793-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    KIWI SEED OIL (UNII: O70FWV3WPP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    CERAMIDE 1 (UNII: 5THT33P7X7)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CORN OIL (UNII: 8470G57WFM)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72793-400-01118 g in 1 TUBE; Type 0: Not a Combination Product02/18/2021
    2NDC:72793-400-024 g in 1 PACKET; Type 0: Not a Combination Product02/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01602/18/2021
    Labeler - Mountainside Medical Equipment, Inc. (119735871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fragrance Manufacturing, Inc.793406000MANUFACTURE(72793-400)
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