Label: ALL PURPOSE- colloidal oatmeal 1.5% 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 June 18, 2015

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Colloidal Oatmeal 1.5%..... Skin Protectant

  • Purpose

    Skin protectant

  • OTC- Warnings Section

    For external use only

    When using this product • do not get into eyes.

    Do not use if you are allergic to plants of the Asteraceae/Compositae/ Daisy family. Hypersensitivity, such as allergy, has been known to occur; in which case, discontinue use.

  • Inactive Ingredients

    Water,Vegetable Glycerin, Calendula, Chamomile, Vitamin A, Vitamin C,Vitamin E, Borage Oil Powder,Tea Tree Essential Oil, Cetyl Alcohol, Rosehip Extract, Grapefruit Seed Extract.

  • Directions

    Apply to affected areas 3-5 times daily as needed.

  • Indications and usage

    • Temporarily protects and helps relieve minor skin irritation and itching due to eczema, insect bites, rashes and dry skin.

  • Package Label

    Box 50mL

    Label 50mL

    Box 15mL

    Label 15mL

  • Questions?

    Call toll-free from US & CA +1-844-881-2882 or visit www.deserving-health.com

  • Keep Out of Reach of Children

    Keep out of reach of children

  • INGREDIENTS AND APPEARANCE
    ALL PURPOSE 
    colloidal oatmeal 1.5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69711-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CHAMOMILE (UNII: FGL3685T2X)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    CITRUS PARADISI SEED (UNII: 12F08874Y7)  
    VITAMIN A (UNII: 81G40H8B0T)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BORAGE OIL (UNII: F8XAG1755S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69711-005-041 in 1 CARTON06/18/2015
    150 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:69711-005-031 in 1 CARTON06/18/2015
    215 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/18/2015
    Labeler - Biological Health Group Corporation (079767886)
    Registrant - Biological Health Group Corporation (079767886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deserving Health International Corp202617023manufacture(69711-005)