HAMSOA YUYU DERMA119 BALM- 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 ingredients : Witch hazel( Hamamelis Virginiana ) 0.1%

INACTIVE INGREDIENT

Inactive ingredients:
Water, Cocamidopropyl Betaine, Lauryl Glucoside, Potassium cocoyl glycinate, TEA-Cocoyl Glutamate, Cocamide Methyl MEA, Citrus Unshiu Fruit Oil, Polyquaternium-10, Polyquaternium-7, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limonum (Lemon) Fruit Oil, Caprylhydroxamic Acid, Caprylyl Glycol, Glycerin, Betaine, Disodium EDTA, Caramel, Glycyrrhiza Glabra (Licorice) Root Extract, Phaseolus Radiatus Seed Extract, Paeonia Albiflora Root Extract, Paeonia Suffruticosa Root Extract, Sophora Angustifolia Root Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Lavandula Angustifolia (Lavender) Extract, Ocimum Basilicum (Basil) Leaf Extract,
Althaea Officinalis Root Extract, Houttuynia Cordata Extract, Anthemis Nobilis Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Panthenol, Prunus Persica (Peach) Leaf Extract, Salix Alba (Willow) Bark Extract, Morus Alba Root Extract, Broussonetia Extract, Sophora Japonica Leaf Extract, Lactobacillus Ferment, Scutellaria Baicalensis Root Extract, Camellia Sinensis Leaf Extract, Artemisia Princeps Leaf Extract, Houttuynia Cordata Extract, Citrus Junos Fruit Extract, Ricinus Communis (Castor) Seed Oil, Portulaca Oleracea Extract, Citric Acid, Squalane

PURPOSE

Purpose: Hair and body wash

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. Thoroughly rinse with water after use on hair to avoid hair loss or bleaching.
5. 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.
6. Try patch test on small area of skin before use or when switching to a new product.
7. Do not place product contents back into container after use to avoid deterioration of quality.
8. This is a cosmetic product not intended to be used by children.

INDICATIONS AND USAGE

INDICATIONS AND USAGE:
Use an appropriate amount and lather well.
Gently massage onto body and hair, and rinse thoroughly

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DOSAGE AND ADMINISTRATION

Recommended amount per use: 1-2g

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

HAMSOA YUYU DERMA119 BALM 
witch hazel cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50964-060
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.009 g  in 9 g
Inactive Ingredients
Ingredient NameStrength
JOJOBA OIL (UNII: 724GKU717M)  
CERESIN (UNII: Q1LS2UJO3A)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
SHEA BUTTER (UNII: K49155WL9Y)  
CYCLOMETHICONE (UNII: NMQ347994Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50964-060-019 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(50964-060)

Revised: 8/2012
Document Id: 27b65d68-18d2-44d1-831c-133737698bd0
Set id: 4d72f02e-f11f-4d07-a0d6-47585e80d7ea
Version: 1
Effective Time: 20120822
 
HAMSOA PHARMACEUTICAL CO., LTD.