Label: LEADERS INSOLUTION COCONUT MASK WITH BLUEBERRY- 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 April 8, 2015

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient: Hamamelis Virginiana (Witch Hazel) Water 0.1%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Butylene Glycol, Acer saccharum (Sugar Maple) extract, Portulaca Oleracea Extract Vaccinium Angustifolium (Blueberry) Fruit Extract, 1, 2-Hexanediol, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Arnica Montana Flower Extract, Artemisia Absinthium Extract Lactobacillus, Leuconostoc Ferment Filtrate, Cocos Nucifera (Coconut) Fruit Extract Betaine, Hydroxyethyl acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Caprylyl Glycol, Ethylhexylglycerin, Saururus Chinensis Extract, Xanthan Gum, Ledum Palustre Extract, Ecklonia Cava Extract, Artemisia Capillaris Flower Extract, Houttuynia Cordata Extract, Fragrance.

  • 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

  • INDICATIONS & USAGE

    Indication and usage: 1. Wipe skin with toner after washing face. Take out mask and remove paper attached to the mask. Attach mask to face according to face shape and remove protection film attached to the outer surface. 2. Take mask off after resting for 20~25 minutes lightly pat face to help essence absorb onto face.

  • DOSAGE & ADMINISTRATION

    Dosage and administration: 2-3 times a week.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    LEADERS INSOLUTION COCONUT MASK WITH BLUEBERRY 
    witch hazel patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69424-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel0.03 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69424-110-0130 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 finalpart34712/01/2014
    Labeler - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
    Registrant - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
    Establishment
    NameAddressID/FEIBusiness Operations
    SANSUNG LIFE & SCIENCE CO., LTD.689524929manufacture(69424-110)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!