Label: HYLANDS NATURALS ECZEMA CREAM- 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 January 3, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients
    Colloidal Oatmeal 1%

  • PURPOSE

    Purpose
    Skin protectant

  • INDICATIONS & USAGE

    Uses
    Temporarily protects and helps relieve minor skin irritation and itching due to: ■ eczema  ■ rashes

  • WARNINGS

    Warnings
    For external use only. When using this product do not get into eyes
    Stop use and ask doctor if ■ condition worsens, ■ symptoms last
    for 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.

  • DOSAGE & ADMINISTRATION

    Directions  ■ Apply as needed.

  • INACTIVE INGREDIENT

    Inactive ingredients  Water, Glycerin, Dicapryl Carbonate,
    Glyceryl Stearate Citrate, Cetearyl Olivate, Sorbitan Olivate, Cetyl

    Alcohol, Lauryl Laurate, Shea Butter, Cocoa Seed Butter, Benzyl

    Alcohol, Dehydroacetic Acid, Xanthan Gum, Linseed Oil, Oat,

    Organic Sunflower Seed Oil, Organic Lavender Flower Extract,

    Organic Calendula Officianalis Flower Extract, Organic Aloe Leaf

    Juice, Hydrolized Quinoa, Pantenol, Citric Acid.

  • QUESTIONS

    Questions? www.hylands.com
    or care@hylands.com

  • Package Labeling

    Hylands

    NATURALS

    • baby •

    ECZEMA
    CREAM

    DERMATOLOGIST TESTED

    NET WT. 5 OZ. (142g)

    DO NOT USE IF TAMPER-EVIDENT SEALIS BROKEN OR MISSING.

    Manufactured for: Hyland’s, Inc., PO Box 61067, Los Angeles, CA 90061
    www.hylands.com | REV001

    Eczema Cream

    res

  • INGREDIENTS AND APPEARANCE
    HYLANDS NATURALS ECZEMA CREAM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-4102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    OAT (UNII: Z6J799EAJK)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-4102-1142 g in 1 TUBE; Type 0: Not a Combination Product12/05/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/05/202212/31/2023
    Labeler - Hylands (008316655)
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