Label: HEALING ECZEMA BALM- 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 January 1, 2022

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  • DRUG FACTS

    DRUG FACTS

  • Active Ingredients

    • Colloidal Oatmeal 1 %
  • Purpose

    Skin Protectant

  • Uses

    Temporarily protects and helps relieve minor skin irritation and itching due to:

    • eczema
    • rashes
    • poison ivy
    • insect bites
  • Warnings

    • Do not use if tamper seal is broken
    • For external use only

    When using this product

    • Do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.

    • If product is swallowed, get medical help or contact a Poison Control Center immediately.

    When using this product

    • Do not get into eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children

    • If product is swallowed, get medical help or contact a Poison Control Center immediately
  • Directions

    • Apply to affected areas of skin as needed
    • Massage into extremely dry, cracked and chafed skin as often as needed for instant relief and long-lasting hydration. Apply generously.
  • Inactive ingredients

    Borago Officinalis (Borage) Seed Oil*, Brassica Oleracea Italica (Broccoli) Seed Oil, Calendula Officinalis Flower Oil*, Cera Alba (Beesawax), Curcuma Longa (Turmeric) Root Oil*, Mangifera Indica (Mango) Seed Butter*, Olea Europaea (Olive) Fruit Oil*, Rosa Canina (Rosehip) Fruit Oil*, Tocopherol (Vitamin E), Zinc Oxide.

    * Certified organic.

  • HEALING ECZEMA BALM 50g (72257-050-00)

    Healing Eczema Balm 50g

  • INGREDIENTS AND APPEARANCE
    HEALING ECZEMA BALM 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72257-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    BROCCOLI SEED OIL (UNII: SY01LVD4G4)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72257-050-001 in 1 BOX09/11/2018
    150 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/11/2018
    Labeler - PROVINCE APOTHECARY INC (201115232)
    Registrant - PROVINCE APOTHECARY INC (201115232)
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