HAMSOA ATOBY MEDI- witch hazel cream 
HAMSOA PHARMACEUTICAL CO., LTD.

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.

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Active ingredient

Active ingredient: Witch hazel(Hamamelis Virginiana) 0.1%

Inactive ingredient

Inactive ingredient:
Water, Butylene Glycol, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Glycerin, Hydrogenated Polydecene, Pentylene Glycol, 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, Cetearyl Alcohol, Macadamia Ternifolia Seed Oil, Glyceryl Stearate, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Butyrospermum Parkii (Shea Butter), Beeswax, Polysorbate 60, Sorbitan Stearate, Dimethicone, Hydrogenated Polydecene, Allantoin, Tremella Fuciformis Sporocarp Extract, 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, Ceramide 3, PEG-10 Rapeseed Sterol, Glycereth-20, Dipropylene Glycol, Malt Extract Concentrated Powder, Laureth-8, Citrus Grandis (Grapefruit) Peel Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Mentha Viridis (Spearmint) Leaf Oil, Arginine, Cananga Odorata Flower Oil, Lavandula Angustifolia (Lavender) Oil, Eucalyptus Globulus Leaf Oil, Pelargonium Graveolens Flower Oil, Citrus Medica Limonum (Lemon) Peel Oil, Abies Sibirica Oil, Citrus Aurantium Dulcis (Orange) Fruit Extract

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

HAMSOA ATOBY MEDI 
witch hazel cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50964-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.05 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50964-050-0150 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(50964-050)

Revised: 8/2012
Document Id: 82953f70-5889-41a5-a1fe-c30ee09ebe43
Set id: 19934a1a-21f2-44de-b7e9-ed0d48def7fa
Version: 1
Effective Time: 20120820
 
HAMSOA PHARMACEUTICAL CO., LTD.