Label: CARIBBEAN COCONUT CALMING MASK- 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

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  • ACTIVE INGREDIENT

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

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Butylene Glycol, 1,2-Hexanediol, Chamomilla Recutita (Matricaria) Flower Extract, Glycerin, Cocos Nucifera (Coconut) Fruit Extract Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Portulaca Oleracea Extract, Acer Saccharum (Sugar Maple) Extract, Betaine, Ethylhexylglycerin, Caprylyl Glycol, Arnica Montana Flower Extract, Xanthan Gum, Hamamelis Virginiana (Witch Hazel) Water, Cocos Nucifera (Coconut) Oil, Fragrance, Artemisia Capillaris Flower Extract, Houttuynia Cordata Extract, Ecklonia Cava Extract, Artemisia Absinthium Extract, Saururus Chinensis Extract, Ledum Palustre Extract, Achillea Millefolium Extract, Leontopodium Alpinum Extract, Gentiana Lutea Root Extract, Opuntia Ficus-Indica Extract, Hydrogenated Lecithin, Panthenol, Sodium Benzoate, Niacinamide, Tocopheryl Acetate, Potassium Sorbate, Citric Acid, Retinyl Palmitate, Biotin, Ascorbic Acid, Folic Acid, Dipotassium Glycyrrhizate, Ceramide 3, Glyceryl Linolenate, Glyceryl Linoleate, Glyceryl Arachidonate

  • 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. Take out mask from pouch and remove protective film from either side of the mask. Step 2. Apply to cleansed face and smooth to fit facial contours. Step 3. Leave mask on face for 20~25 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
    CARIBBEAN COCONUT CALMING MASK 
    witch hazel patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69424-230
    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:69424-230-0130 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 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(69424-230)
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