Label: SKIN PROTECTANT- colloidal oatmeal ointment

  • 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 25, 2014

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  • Active Ingredient

    Colloidal Oatmeal 1.0%

  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritations and itching due to 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 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 or recommended 3-4 x a day initially during flare up and as needed after flareup begins to subside
    • Apply generously before bed to help avoid itching while sleeping
  • Storage

    Store at room temperature

  • Inactive Ingredients

    USP White Petrolatum, Lemon Concentrate, Glycerin, Honey, Prunus Amygdalus Dulcis (Almond Oil), Alpha tocopherol (Vitamin E), Beeswax, Soy Wax, Talc, Boric acid, Zinc oxide, Stearic acid, Pistachia lenticus (Mastica), Vanilla

  • Questions or Comments

    1-844-Buy-ELAJ (949-581-1200) or visit www.elajnaturally.com

  • Product Packaging Labels

    57 g, 113 g, and 227 g Box Labels

    57 g, 113 g, and 227 g Box Labels

    57 g, 113 g, and 227 g Container Labels

    57 g, 113 g, and 227 g Container Labels

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69123-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.57 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HONEY (UNII: Y9H1V576FH)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Talc (UNII: 7SEV7J4R1U)  
    BORIC ACID (UNII: R57ZHV85D4)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Vanilla (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69123-111-011 in 1 BOX
    157 g in 1 CONTAINER
    2NDC:69123-111-021 in 1 BOX
    2113 g in 1 CONTAINER
    3NDC:69123-111-031 in 1 BOX
    3227 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34707/25/2014
    Labeler - ELAJ, LLC (051975632)
    Registrant - ELAJ, LLC (051975632)
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