Label: HAMSOA YUYU DERMA119- witch hazel cream

  • 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 August 22, 2012

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

  • ACTIVE INGREDIENT

    Active ingredient: Witch hazel( Hamamelis Virginiana ) 0.1%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    Water, Glycerin, Butylene Glycol, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Helianthus Annuus (Sunflower) Seed Oil, 1,2-Pentanediol,
    Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Hydrogenated Polydecene, Beeswax,
    Sorbitan Stearate, Dimethicone, Polysorbate 60, Laureth-8, Disodium EDTA, Citrus Aurantium Dulcis (Orange) Oil, Triethanolamine, Ceramide 3, Glycyrrhiza Glabra (Licorice) Root Extract, Phaseolus Radiatus Seed Extract, Caramel, Velvet Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Macadamia Ternifolia Seed Oil, Olea Europaea (Olive) Fruit Oil, Persea Gratissima (Avocado) Oil, Camellia Japonica Seed Oil, Scutellaria Baicalensis Root Extract, Sophora Angustifolia Root Extract, Paeonia Albiflora Root Extract, paeonia Suffruticosa Root Extract, Citrus Medica Limonum (Lemon) Fruit Oil, Oryza Sativa (Rice) Extract, Solanum Tuberosum (Potato) Pulp Extract, Brassica oleracea Capitata (Cabbage) Leaf Extract, Brassica oleracea Acephala Leaf Extract, Daucus Carota Sativa (Carrot) Root Extract, Brassica Oleracea Italica (Broccoli) Extract, Apium Graveolens (Celery) Extract, Phellinus Linteus Extract, Ganoderma Lucidum (Mushroom) Extract, Tricholoma Matsutake Extract, Betula Platyphylla Japonica Juice, Bupleurum Falcatum Root Extract, Ophiopogon Japonicus Root Extract, Asparagus Cochinchinensis Root Extract, Angelica Gigas Root Extract, Hydrogenated Lecithin, Chamomilla Recutita (Matricaria) Flower/Leaf Extract,
    Ficus Carica (Fig) Fruit Extract, Punica Granatum Fruit Extract, Pueraria Lobata Root Extract, Cimicifuga Racemosa Root Extract,
    Codonopsis Lanceolata Root Extract, Sodium Hyaluronate

  • PURPOSE

    Purpose: Skin moisturizer

  • WARNINGS

    Warnings
    1. Stop use immediately if the following symptoms occur, and consult a dermatologist.
    A) If use of the product causes red spots, swelling, itching, or other irritation
    B) If direct sunlight causes the symptoms listed above
    2. Do not use on areas of injury, rash, or skin inflammation.
    3. Keep out of eyes when using the products. Immediately rinse with water in case of eye contact.
    4. Storage and safety precautions
    A) Close lid tightly when not in use.
    B) Keep out of reach of children and infants.
    C)Do not store in high/low temperatures, and keep away from sunlight.
    5. Try patch test on small area of skin before use or when switching to a new product.
    6. Do not place product contents back into container after use to avoid deterioration of quality.
    7. This is a cosmetic product not intended to be used by children

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep away from children and infants.
    This is a cosmetic product not intended for consumption.

  • INDICATIONS AND USAGE

    Directions:
    Use several times a day after taking a bath or washing face.
    Apply an appropriate amount and massage gently onto skin for better absorption.
    Be thorough for dried skin areas such as the face, neck, inner arm, knees, and calves to offer better protection for sensitive, troubled skin.

  • DOSAGE AND ADMINISTRATION

    Recommended amount per use: 1-2g

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    HAMSOA YUYU DERMA119 
    witch hazel cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50964-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.08 g  in 80 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50964-070-0180 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2012
    Labeler - HAMSOA PHARMACEUTICAL CO., LTD. (690417753)
    Registrant - HAMSOA PHARMACEUTICAL CO., LTD. (690417753)
    Establishment
    NameAddressID/FEIBusiness Operations
    HAMSOA PHARMACEUTICAL CO., LTD.690417753manufacture(50964-070)