HAMSOA ATOBY MEDI BATH AND

Dosage form: shampoo
Ingredients: WITCH HAZEL 0.25g in 250mL
Labeler: HAMSOA PHARMACEUTICAL CO., LTD.
NDC Code: 50964-030

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.

ACTIVE INGREDIENT

Active ingredient: Witch hazel(Hamamelis Virginiana) 0.1%

INACTIVE INGREDIENT

Inactive ingredient:
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.

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

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

DOSAGE AND ADMINISTRATION

Recommended amount per use: 1-2g

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

HAMSOA ATOBY MEDI BATH AND 
witch hazel shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50964-030
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL0.25 g  in 250 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
COCAMIDOPROPYL BETAINE 
LAURYL GLUCOSIDE 
CITRUS RETICULATA FRUIT OIL 
Packaging
#Item CodePackage Description
1NDC:50964-030-01250 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/FEIOperations
HAMSOA PHARMACEUTICAL CO., LTD.690417753manufacture(50964-030)

Revised: 08/2012
 
HAMSOA PHARMACEUTICAL CO., LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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