Label: HAMSOA YUYU DERMA119 BALM- witch hazel cream
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Contains inactivated NDC Code(s)
NDC Code(s): 50964-060-01 - Packager: HAMSOA PHARMACEUTICAL CO., LTD.
- 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 22, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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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
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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
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE AND ADMINISTRATION
- PACKAGE LABEL. PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HAMSOA YUYU DERMA119 BALM
witch hazel creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50964-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL 0.009 g in 9 g Inactive Ingredients Ingredient Name Strength JOJOBA OIL (UNII: 724GKU717M) CERESIN (UNII: Q1LS2UJO3A) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) SHEA BUTTER (UNII: K49155WL9Y) CYCLOMETHICONE (UNII: NMQ347994Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50964-060-01 9 g in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 03/01/2012 Labeler - HAMSOA PHARMACEUTICAL CO., LTD. (690417753) Registrant - HAMSOA PHARMACEUTICAL CO., LTD. (690417753) Establishment Name Address ID/FEI Business Operations HAMSOA PHARMACEUTICAL CO., LTD. 690417753 manufacture(50964-060)
