Label: HAMSOA ATOBY MEDI- witch hazel lotion

  • 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 20, 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, Sorbitol, Lavandula Angustifolia (Lavender) Extract, Ocimum Basilicum (Basil) Extract, Althaea Officinalis Extract, Houttuynia Cordata Extract, Anthemis Nobilis Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Hydrogenated Polydecene, Glycerin, Cetyl Ethylhexanoate, Pentylene Glycol, Stearic acid, Betaine, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, Cetearyl Alcohol, Cetearyl Glucoside, Hydrogenated Lecithin, Butyrospermum Parkii (Shea Butter), Dimethicone, Allantoin, Carbomer, Arginine, Tremella Fuciformis Sporocarp Extract, Butylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Tropolone, Citrus Unshiu Fruit Oil, Disodium EDTA, Portulaca Oleracea Extract, Coptis Japonica Root Extract, Salvia Miltiorrhiza Root Extract, Schizandra Chinensis Fruit Extract, Rhus Semialata Gall Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Vigna Radiata Seed Extract, Scutellaria Baicalensis Root Extract, Sophora Angustifolia Root Extract, Paeonia Suffruticosa Root Extract, Paeonia Albiflora Root Extract, Citrus Grandis (Grapefruit) Peel Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Mentha Viridis (Spearmint) Leaf Oil, Ceramide 3, PEG-10 Rapeseed Sterol, Glycereth-20, Dipropylene Glycol, Malt Extract Concentrated Powder, Cananga Odorata Flower Oil, Lavandula Angustifolia (Lavender) Oil,
    Eucalyptus Globulus Leaf Oil, Pelargonium Graveolens Flower Oil, Citrus Medica Limonum (Lemon) Peel Oil, Citrus Aurantium Dulcis (Orange) Fruit Extract, Abies Sibirica Oil

  • 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.

  • DOSAGE AND ADMINISTRATION

    Recommended amount per use: 1-2g

  • INDICATIONS AND USAGE

    INDICATIONS AND USAGE:
    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, dried skin.
    Use both Atoby Medi Lotion and Atoby Medi Cream for maximum effectiveness in areas of severe dryness and in sensitive/troubled areas.

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    HAMSOA ATOBY MEDI 
    witch hazel lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50964-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.15 g  in 150 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BASIL (UNII: 2U0KZP0FDW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50964-040-01150 mL 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(50964-040)