Label: THERESIENOL MD SKIN PROTECTANT- lanolin liquid

  • NDC Code(s): 72184-001-01, 72184-001-04, 72184-001-15, 72184-001-20
  • Packager: Fordee Group, LLC
  • 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 August 2, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Lanolin 12.5%

  • PURPOSE

    Purpose

    Skin protectant

  • INDICATIONS & USAGE

    Uses temporarily protects

    • minor cuts, scrapes and burns
    • chafed, chapped or cracked skin
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • WHEN USING

    When using this product do not get into eyes

  • STOP USE

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again in a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions apply as needed

  • STORAGE AND HANDLING

    Other information

    • store between 46°-77°F (8°-25°C)
    • use within 6 months of opening
  • INACTIVE INGREDIENT

    Inactive ingredients

    Apple Fruit Extract, Chicken Fat Extract, Clarified Butter, Pentylene Glycol, Sea Onion Leaf Extract, Tocopherol, Tocopherol Acetate

  • SPL UNCLASSIFIED SECTION

    Multi-purpose natural skin care serum with lanolin for all skin types, all ages & all stages.

    Works naturally with your body.

    • Protects and helps relieve minor burns
    • Protects and helps relieve minor scrapes
    • Helps relieve & heals cracked or chapped skin
    • Soothes, hydrates & protects irritated skin
    • Natural ingredients

    Exclusively distributed by:

    4DG

    1700 Post Oak Blvd.

    2BLVD PLACE, Suite 600

    Houston, TX 77056, USA

    www.4DG.life

    Made in Austria

  • SPL UNCLASSIFIED SECTION

    Skin protectant drug product.

    A drug product that temporarily protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli, and may help provide relief to such surfaces.

  • PRINCIPAL DISPLAY PANEL

    Theresienol MD

    Multi-purpose

    SKIN PROTECTANT+ with LANOLIN

    for minor

    BURNS+CUTS+SCRAPES

    NATURAL SKIN SERUM

    0.5 fl. oz. / 15ml

    Riviera Skin Serum Final

  • INGREDIENTS AND APPEARANCE
    THERESIENOL MD SKIN PROTECTANT 
    lanolin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72184-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN12.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALBUCA BRACTEATA WHOLE (UNII: GK156DX76Z)  
    BUTTER (UNII: 3B7C0987O9)  
    CHICKEN FAT (UNII: A2OSN87060)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    APPLE FRUIT OIL (UNII: 9NT987I3A8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72184-001-151 in 1 CARTON03/26/2018
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:72184-001-041 in 1 CARTON03/26/2018
    240 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:72184-001-201 in 1 CARTON03/26/2018
    3200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    4NDC:72184-001-0110 in 1 CARTON03/26/2018
    41 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/26/201807/31/2025
    Labeler - Fordee Group, LLC (081100199)
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