Label: LEADERS COCONUT MASK WITH BROCCOLI- witch hazel patch

  • 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 28, 2016

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  • ACTIVE INGREDIENT

    [Active Ingredient] Hamamelis Virginiana (Witch Hazel) Water 0.1%

  • INACTIVE INGREDIENT

    [Inactive Ingredients] Water, Methylpropanediol, Butylene Glycol, Chamomilla Recutita (Matricaria) Flower Extract, Dipropylene Glycol, Lactobacillus/Leuconostoc/Brassica Oleracea Italica (Broccoli) Extract, 1, 2-Hexanediol, Lactobacillus/Leuconostoc/Cocos Nucifera (Coconut) Fruit Extract, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Betaine, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Fragrance, Polysorbate 60, Sorbitan Isostearate, Artemisia Capillaris Flower Extract, Ecklonia Cava Extract, Houttuynia Cordata Extract, Ledum Palustre Extract, Saururus Chinensis Extract, Achillea Millefolium Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Gentiana Lutea Root Extract.

  • PURPOSE

    [Purpose] Skin Protectant

  • WARNINGS

    [Warning] 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]

    1) Clean and dry face. 2) Remove mask from package and peel off one side of the protective paper. 3) Place mask directly on skin, contouring it to fit the curves around the eyes, nose and mouth. 4) Remove the protective film from the outside of the mask. 5) Leave on for 10-20 minutes. 6) Remove mask and gently pat the face with fingertips until the remaining serum is fully absorbed. *Suggested use is 2-3 times a week.

  • Directions

    [Directions]

    1) Clean and dry face. 2) Remove mask from package and peel off one side of the protective paper. 3) Place mask directly on skin, contouring it to fit the curves around the eyes, nose and mouth. 4) Remove the protective film from the outside of the mask. 5) Leave on for 10-20 minutes. 6) Remove mask and gently pat the face with fingertips until the remaining serum is fully absorbed. *Suggested use is 2-3 times a week.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of cello pack

  • INGREDIENTS AND APPEARANCE
    LEADERS COCONUT MASK WITH BROCCOLI 
    witch hazel patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69424-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel30 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Methylpropanediol (UNII: N8F53B3R4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69424-350-0130 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(69424-350)