Label: HAMSOA YUYU DIAPER- 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 16, 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, Caprylic/Capric Triglyceride, Glycerin, Butylene Glycol, Hydrogenated Polydecene, Panthenol, 1,2-Pentanediol, Helianthus Annuus (Sunflower) Seed Oil, Calendula Officinalis Flower Extract, Glyceryl Stearate, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cyclomethicone, Cetearyl Alcohol, Beeswax, Sorbitan Stearate, Polysorbate 60, Arginine, Citrus Unshiu Fruit Oil, Laureth-8, Macadamia Ternifolia Seed Oil, Disodium EDTA, Brassica Campestris (Rapeseed) Sterols, PEG-5 Rapeseed Sterol, Cholesterol, Beta-Sitosterol, Phaseolus Radiatus Seed Extract, Ceramide 3, Hydrogenated Lecithin, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Olea Europaea (Olive) Fruit Oil, Persea Gratissima (Avocado) Oil, Camellia Japonica Seed Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Salvia Miltiorrhiza Root Extract, Schizandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Rhus Semialata Gall Extract, Choleth-24, Ceteth-24, Polyglutamic Acid, Creatine, Sodium Hyaluronate, Paeonia Albiflora Root Extract, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Sophora Angustifolia Root Extract, Cetyl Phosphate, Citrus Medica Limonum (Lemon) Fruit Oil, Citrus Aurantifolia (Lime) Oil, Cymbopogon Schoenanthus Oil, Citrus Aurantium Dulcis (Orange) Oil, BHT

  • PURPOSE

    Purpose: Skin moisture and relief product

  • 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:
    Dry skin well after changing diapers and gently apply the Hamsoa Diaper Cream to sensitive and troubled skin under diapers.
    Apply on buttocks, groins, and diaper band areas.

  • DOSAGE AND ADMINISTRATION

    Recommended amount per use: 1-2g or as needed

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    HAMSOA YUYU DIAPER 
    witch hazel cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50964-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.07 g  in 70 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50964-010-0170 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(50964-010)