Label: LEADERS MEDIU CALMING PEPPERMINT PACK- allantoin gel

  • 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 1, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Allantoin 0.51%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Phaseolus angularis seed powder, Butylene Glycol, Kaolin, Bentonite, Magnesium aluminum silicate, PVP, Cellulose, Caramel, Chromium Oxide greens, Betaine, Titanium dioxide, Aloe barbadensis leaf water, Daucus carota sativa (carrot) root extract, Cucurbita pepo (pumpkin) fruit extract, Disodium EDTA, Mentha piperita (peppermint) oil, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Phenoxyethanol, Chlorphenesin

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Not for human consumption. Discontinue use if irritation occurs. If irritation persists, consult a physician.

    Use immediately after opening. Store in cool and dry place. Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Directions

    Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week

  • Directions

    Directions: After cleansing face, apply a thin layer of the Wash-Off Pack on the face, leaving out the area around eyes and mouth. Leave on for 5-10 minutes then wash off with tepid water. *Suggested use is 2-3 times a week

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of cello pack

  • INGREDIENTS AND APPEARANCE
    LEADERS MEDIU CALMING PEPPERMINT PACK 
    allantoin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69424-450
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Allantoin (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) Allantoin51.0 mg  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ADZUKI BEAN (UNII: 31GYU1X0FP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69424-450-0110 mL in 1 CELLO PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/01/2015
    Labeler - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
    Registrant - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
    Establishment
    NameAddressID/FEIBusiness Operations
    SANSUNG LIFE & SCIENCE CO., LTD.689524929manufacture(69424-450)
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