Label: HEALING ECZEMA BALM- oatmeal cream

  • NDC Code(s): 72257-001-15, 72257-001-80
  • Packager: PROVINCE APOTHECARY INC
  • 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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  • HEALING ECZEMA BALM

    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
  • Warnings

    • 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.
  • 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

    • Olea Europaea (Olive) Oil, Zinc Oxide, Cera Alba (Beesawax), Calendula Officinalis Flower Oil, Borago Officinalis (Borage) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Symphytum Officinale (Comfrey) Root Extract, Brassica Oleracea Italica (Broccoli) Seed Oul, Rosa Canina (Rosehip) Fruit Oil, Tocopherol (Vitamin E), Hypericum Perforatum (St.John's Wort) Oil, Propolis Cera, Curcuma Longa (Turmeric) Root Oil.
  • HEALING ECZEMA BALM 15g (72257-001-15)

    HEB_15

  • ECZEMA BALM 80g (72257-001-80)

    HEB_80g

  • Drug Facts

    DrugFacts1

    DrugFacts2

  • INGREDIENTS AND APPEARANCE
    HEALING ECZEMA BALM 
    oatmeal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72257-001
    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
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    BORAGO OFFICINALIS SEED (UNII: 2GXJ790US0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    COMFREY ROOT (UNII: M9VVZ08EKQ)  
    BROCCOLI SEED OIL (UNII: SY01LVD4G4)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    TURMERIC OIL (UNII: 6KGS8SP16U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72257-001-151 in 1 BOX09/11/2018
    115 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:72257-001-801 in 1 BOX09/11/2018
    280 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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