Label: SKIN SOOTHING CREAM - NUT FREE- 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 December 7, 2020

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  • ACTIVE INGREDIENT

    Active Ingredient: Colloidal Oatmeal 1.0%

  • PURPOSE

    Purpose: Skin Protectant

  • INDICATIONS & USAGE

    Uses:

    • Temporarily protects and helps relieve minor skin iritation and itching due to rashes and eczema.
  • WARNINGS

    Warning:

    • For external use only.
  • STOP USE

    Stop use and ask a Doctor if:

    • Condition worsens
    • Symptoms last more than 7 days or clear up and occur again within few days
  • WHEN USING

    When using this product - do not get into eyes.

  • 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 evenly to your skin. Apply lightly and use 1-3 times a day as needed.

  • INACTIVE INGREDIENT

    Vitis Vinifera (Grape) Seed Oil, Honey*, Aloe Barbadensis Leaf Juice*, Beeswax, Helianthus Annus (sunflower) seed oil*, Water (Aqua), Sodium Bicarbonate, Phenoxyethanol, Potassium Sorbate, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol

    * Refers to Certified Organics.

  • OTHER SAFETY INFORMATION

    Other Information:

    Store Below 30ºC. (86ºF)

  • QUESTIONS

    Questions or comments?

    Call to toll free number (707) 652-3438

    email: ariel@eczemahoneyco.com

  • PRINCIPAL DISPLAY PANEL

    Manufactured for:

    Eczema Honey Co, LLC

    Hayward CA-94544

    Skin Soothing Cream-Nut Free

  • INGREDIENTS AND APPEARANCE
    SKIN SOOTHING CREAM - NUT FREE 
    colloidal oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4194
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    WATER (UNII: 059QF0KO0R)  
    HONEY (UNII: Y9H1V576FH)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4194-1113.5 g in 1 JAR; Type 0: Not a Combination Product12/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/07/2020
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4194)
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