Label: BABO BOTANICALS SENSITIVE BABY HEALING- colloidal oatmeal ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

  • Active Ingredient

    Colloidal Oatmeal 1%

  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects and helps relieve minor skin irritation and itching due to
    • rashes
    • eczema
    • poison ivy ,oak, or sumac
    • insect bites
  • Warnings

    For external use only.

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • conditions 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 immediately.

  • Directions

    • Apply as needed.
    • Children under 3 months: ask a doctor.
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive Ingredients

    Helianthus Annuus (Sunflower) Seed Oil*, Beeswax*, Olea Europoaea (Olive) Fruit Oil*, Butyrospermum Parkii (Shea) Butter*, Calendula Officinalis Flower Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Nasturtium Officinale (Watercress) Flower/Leaf Extract*, Spiraea Ulmaria (Meadowsweet) Flower Extract*, Bisabolol*, Theobroma Cacao (Cocoa) Seed Butter*, Rosmarinus Officinalis (Rosemary) Leaf Extract*.

    *Certified Organic Ingredients

  • Questions or comments?

    Call 1-800-422-2987 M-F 9:00AM-5:00PM EST

  • Company Information

    Dist: by Babo Botanicals, Inc.

    60 East 56th Street

    New York, NY 10022

  • Product Packaging

    1

  • INGREDIENTS AND APPEARANCE
    BABO BOTANICALS SENSITIVE BABY HEALING 
    colloidal oatmeal ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79265-8655
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    NASTURTIUM OFFICINALE FLOWERING TOP (UNII: W1N2U8I64G)  
    FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ROSEMARY (UNII: IJ67X351P9)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79265-8655-11 in 1 BOX10/23/2023
    1113 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/23/2023
    Labeler - Babo Botanicals, Inc. (058258734)
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