HAMSOA YUYU DIAPER- 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 ingredients:
Water, Caprylic/Capric Triglyceride, Glycerin, Butylene Glycol, Hydrogenated Polydecene, Panthenol, 1,2-Pentanediol, Helianthus Annuus (Sunflower) Seed Oil, Calendula Officinalis Flower Extract, Glyceryl Stearate, PEG-100 Stearate, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Cyclomethicone, Cetearyl Alcohol, Beeswax, Sorbitan Stearate, Polysorbate 60, Arginine, Citrus Unshiu Fruit Oil, Laureth-8, Macadamia Ternifolia Seed Oil, Disodium EDTA, Brassica Campestris (Rapeseed) Sterols, PEG-5 Rapeseed Sterol, Cholesterol, Beta-Sitosterol, Phaseolus Radiatus Seed Extract, Ceramide 3, Hydrogenated Lecithin, Saccharide Isomerate, Simmondsia Chinensis (Jojoba) Seed Oil, Olea Europaea (Olive) Fruit Oil, Persea Gratissima (Avocado) Oil, Camellia Japonica Seed Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Salvia Miltiorrhiza Root Extract, Schizandra Chinensis Fruit Extract, Coptis Japonica Root Extract, Rhus Semialata Gall Extract, Choleth-24, Ceteth-24, Polyglutamic Acid, Creatine, Sodium Hyaluronate, Paeonia Albiflora Root Extract, Paeonia Suffruticosa Root Extract, Scutellaria Baicalensis Root Extract, Sophora Angustifolia Root Extract, Cetyl Phosphate, Citrus Medica Limonum (Lemon) Fruit Oil, Citrus Aurantifolia (Lime) Oil, Cymbopogon Schoenanthus Oil, Citrus Aurantium Dulcis (Orange) Oil, BHT

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.
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.

INDICATIONS AND USAGE

Directions:
Dry skin well after changing diapers and gently apply the Hamsoa Diaper Cream to sensitive and troubled skin under diapers.
Apply on buttocks, groins, and diaper band areas.

DOSAGE AND ADMINISTRATION

Recommended amount per use: 1-2g or as needed

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

HAMSOA YUYU DIAPER 
witch hazel cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50964-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.07 g  in 70 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PANTHENOL (UNII: WV9CM0O67Z)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50964-010-0170 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(50964-010)

Revised: 8/2012
Document Id: a38de797-1191-4d34-9f28-1fed2ba36ada
Set id: 0929b61f-cfc2-4cc5-b700-d577ae7d6cff
Version: 2
Effective Time: 20120816
 
HAMSOA PHARMACEUTICAL CO., LTD.