HAMSOA DR ATOBY MIST- witch hazel solution 
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 ingredients:
Water, Glycerin, Pentylene Glycol,Biosaccharide Gum-1, PEG-32, Butylene Glycol, Sodium Hyaluronate, Bambusa Vulgaris Sap Extract, Mentha Piperita (Peppermint) Leaf Water, Angelica Gigas Root Extract, Rehmannia Chinensis Root Extract , Saposhnikovia Divaricata Root Extract, Atractyloides Chinensis Rhizome Extract, Akebia Quinata Stem Extract, Arctium Lappa Fruit Extract, Anemarrhena Asphodeloides Root Extract, Schizonepeta Tenuifolia Extract,Sophora Angustifolia Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract,
Citrus Paradisi (Grapefruit) Fruit Extract, Scutellaria Baicalensis Root Extract, Coptis Chinensis Root Extract, Phellodendron Amurense Bark Extract, Portulaca Oleracea Extract, Calendula Officinalis Flower Extract, Equisetum Arvense Extract, Hydrolyzed Jojoba Esters, Betaine, Fulvic Acid, PEG-60 Hydrogenated Castor Oil, Glycine Soja (Soybean) Seed Extract, Centella Asiatica Extract, Anthemis Nobilis Flower Extract, Echium Plantagineum Seed Oil, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Astrocaryum Murumuru Seed Butter, Copper Tripeptide-1, Allantoin, Disodium EDTA, Olea Europaea (Olive) Fruit Oil,
Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Jasminum Officinale (Jasmine) Oil, Rose Flower Oil, Vanilla Planifolia Fruit Extract, Thuja Occidentalis Leaf Extract, Cedrus Atlantica Bark Oil, Ferula Galbaniflua (Galbanum) Resin Oil, Pelargonium Graveolens Flower Oil, Citrus Grandis (Grapefruit) Peel Oil, Lavandula Angustifolia (Lavender) Oil, Myrtus Communis Oil, Citrus Aurantium Dulcis (Orange) Fruit Extract

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.
D) Do not store in areas of high heat above 40 degrees.
E) Keep away from fire.
F) Make sure to discard all remaining gas before disposal.
G) Do not store in a sealed area.
6. Try patch test on small area of skin before use or when switching to a new product.
7. Shake well before use.
8. Do not spray on the same area for more than 3 seconds.
9. Maintain at least 20cm distance from the body when applying the product.
10. Do not spray near the eyes.
11. Make sure to avoid ingestion of product.

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 per day on troubled, red, and itchy skin by spraying an appropriate amount from a 20cm distance.

DOSAGE AND ADMINISTRATION

Recommended amount per use: 1-2ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

HAMSOA DR ATOBY MIST 
witch hazel solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50964-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.06 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50964-110-0160 mL in 1 CARTON; Type 0: Not a Combination Product03/01/201212/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/201212/30/2014
Labeler - Hamsoa Pharmaceutical Co., Ltd. (690417753)
Registrant - Hamsoa Pharmaceutical Co., Ltd. (690417753)
Establishment
NameAddressID/FEIBusiness Operations
Hamsoa Pharmaceutical Co., Ltd.690417753manufacture(50964-110)

Revised: 11/2017
 
Hamsoa Pharmaceutical Co., Ltd.