Label: ATOPIS ECZEMA THERAPY 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 July 9, 2019

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  • ACTIVE INGREDIENT

    Colloidal Oatmeal 0.5%

  • PURPOSE

    Colloidal Oatmeal 0.5%...... Skin Protectant

  • INDICATIONS & USAGE

    temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema • insect bites

  • 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.

  • DOSAGE & ADMINISTRATION

    Apply twice daily for best results.

  • STORAGE AND HANDLING

    • Safe for the face and body.
    • External use only. If irritation should occur discontinue use.
    • When using this product you may notice a slight tingling sensation; this is normal and will subside.
    • Do not use if quality seal is broken or missing.

  • INACTIVE INGREDIENT

    Myriphytase extract (Cocos nucifera (coconut) water, Bee pollen, Cocos nucifera coconut) oil, Notofagus fuca honeydew), Cetearyl olivate, Sorbitan olivate, Carthamus tinctorius (Safflower) seed oil, Cetearyl alcohol, Glycerin, Macadamia ternifolia seed oil, Butyrospermum parkii (shea butter), Tocopheryl acetate, Sodium stearoyl glutamate, benzyl alcohol, dehydracetic acid, Citrus aurantium bergamia (bergamot) fruit oil, Xanthan gum, Citric acid.

  • QUESTIONS

    (855) 969-5002 or contact@atopis.com

  • PRINCIPAL DISPLAY PANEL

    ATOPIS

    Eczema
    Therapy Cream

    Skin Protectant


    Cream for eczema, rash and insect bite relief

    Clinically shown to relieve and protect dry, itchy, irritated skin, due to eczema


    • Soothes, nourishes and restores moisture
    • No parabens, no solvents, no artificial fragrances
    • Clinically trialed on humans, not tested on animals

    Product of New Zealand
    E Net Wt 2.6 oz/75g

    Atopis

  • INGREDIENTS AND APPEARANCE
    ATOPIS ECZEMA THERAPY CREAM 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71570-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT WATER (UNII: 267F5Y81NT)  
    BEE POLLEN (UNII: 3729L8MA2C)  
    HONEYDEW MELON (UNII: RN8P45F92A)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71570-001-011 in 1 CARTON07/15/2019
    175 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/15/2019
    Labeler - Bionona Limited (594871226)
    Establishment
    NameAddressID/FEIBusiness Operations
    I. Shay Cosmetics, Inc.151582384manufacture(71570-001)
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