VASHTI (ALLANTOIN) CREAM [LEADER GREEN CO., LTD.]

VASHTI (ALLANTOIN) CREAM [LEADER GREEN CO., LTD.]
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NDC 61221-020-01
Set ID 7e59b578-161b-458e-953f-ee1da7d456e5
Category HUMAN OTC DRUG LABEL
Packager LEADER GREEN CO., LTD.
Generic Name
Product Class
Product Number
Application Number PART347
  • ACTIVE INGREDIENT

    Active ingredient: Allantoin 0.5%

  • INACTIVE INGREDIENT

    Inactive ingredients: PONCIRUS TRIFOLIATA FRUIT, NARINGINASE, LOBELIA SPICATA LEAF, MINERAL OIL, VITAMINE C

  • Purpose

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:
    1. In case of having following symptoms after using this, you're advised to stop using it immediately. If you keep using it, the symptoms will get worse and need to consult a dermatologist.
    1) In case of having problems such as red rash, swollenness, itching, stimulation during usage.
    2) In case of having the same symptoms above on the part you put this product on by direct sunlight.
    2. You are banned to use it on the part where you have a scar, eczema, or dermatitis.
    3. In case of getting it into your eyes, you have to wash it immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of babies and children

  • Indications and usage

    Indications and usage:
    After basic skin care, apply adequate amount following the skin texture and gently tap to enhance absorption.

  • Dosage and administration

    Dosage and administration:
    Take an adequate amount of this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    VASHTI 
    allantoin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61221-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin0.25 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    LOBELIA SPICATA LEAF (UNII: 1G4GK01F67)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61221-020-0150 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34711/01/2013
    Labeler - LEADER GREEN CO., LTD. (688735493)
    Registrant - LEADER GREEN CO., LTD. (688735493)
    Establishment
    NameAddressID/FEIBusiness Operations
    LEADER GREEN CO., LTD.688735493manufacture(61221-020)

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