Label: XLENTSKIN- lanolin, petrolatum ointment

  • 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 February 16, 2022

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  • DRUG FACTS

  • Active Ingredients

    Lanolin 15.5%

    Petrolatum 30%

  • Purpose

    Skin protectant

  • Uses

    • Temporarily protects minor cuts, scrapes and burns

    • Temporarily protects and helps relieve chafed, chapped or cracked skin or lips

    • Helps protect from the drying effect of wind and cold weather

  • WARNINGS

    Warnings - For external use only

    Do not use :
    • On deep or puncture wound
    • Animal bites
    • Serious burns
    • If skin allergy problem occurs

    When using this product :
       Avoid contact with eyes or mouth, avoid eat seafood or hot food

    Stop use and ask a doctor if :
    • Condition Worsens
    • Symptom clear up and occur again within a few days
    • Symptom persist for more than 7 days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children to avoid accidental poisoning If swallowed get medical help or consult a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Mix the product into paste, apply evenly on the wound with the thickness of 1 -2 mm, bind with gauze and adhesive tape. Use once every two days.

  • Inactive ingredients :

    Huang Se (Astragalus membranaceus) root, Mastic pistacis lentiscus) resin, Myrrh (Commiphora myrrha) resin, Calamine (zinc oxide and ferric oxide), sesame oil

  • Other information :

    • When storing, keep it away from sun exposure

  • SPL UNCLASSIFIED SECTION

    First – Aid Ointment
    Skin Protectant
    For cuts, dry cracked skin, burns, chafed skin, scrapes, and chapped lips
    Product of China
    U.S Distributer :
    Jiang’s Biotechnology Co. Diamond Bar, CA 91765

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    XLENTSKIN 
    lanolin, petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71649-3776
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN15.5 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ASTRAGALUS PROPINQUUS ROOT (UNII: 922OP8YUPF)  
    PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
    MYRRH (UNII: JC71GJ1F3L)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SESAME OIL (UNII: QX10HYY4QV)  
    Product Characteristics
    Colorbrown (light brown) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71649-3776-51 in 1 BOX04/23/2017
    130 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/23/2017
    Labeler - Jiangsu Jiang Shi Biological Technology Co., Ltd. (544038366)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Jiang Shi Biological Technology Co., Ltd.544038366manufacture(71649-3776)
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