Label: BREAKUP WITH YOUR EX SKIN CELLS- 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 May 29, 2015

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

  • ACTIVE INGREDIENT

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

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Butylene Glycol, Glycerin, Chamomilla Recutita (Matricaria) Flower Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Portulaca Oleracea Extract, Betaine, Acer Saccharum (Sugar Maple) Extract, Ethylhexylglycerin, Caprylyl Glycol, Arnica Montana Flower Extract, Xanthan Gum, Houttuynia Cordata Extract, Sodium Hyaluronate, Fragrance, Epilobium Fleischeri Extract, Ledum Palustre Extract, Saururus Chinensis Extract, Artemisia Absinthium Extract, Artemisia Capillaris Flower Extract, Ecklonia Cava Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Potassium Sorbate, Citric Acid, Acetyl Dipeptide-3 Aminohexanoate

  • 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

  • INDICATIONS & USAGE

    Indication and usage: Step 1. Remove mask from the pouch and gently unfold. Step 2. Apply mask to cleansed skin and smooth to fit contours of face. Step 3. Leave on for 10~15 minutes. Step 4. Discard mask and lightly pat face to help absorb serum into skin.

  • DOSAGE & ADMINISTRATION

    Dosage and administration: 2-3 times a week. Each mask is for one time use only.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of cello pack

  • INGREDIENTS AND APPEARANCE
    BREAKUP WITH YOUR EX SKIN CELLS 
    witch hazel patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69424-290
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Witch Hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) Witch Hazel0.025 mg  in 25 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69424-290-0125 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 finalpart34703/01/2015
    Labeler - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
    Registrant - SANSUNG LIFE & SCIENCE CO., LTD. (689524929)
    Establishment
    NameAddressID/FEIBusiness Operations
    SANSUNG LIFE & SCIENCE CO., LTD.689524929manufacture(69424-290)