JEUNCELL a Drug For Atopic Dermatitis: Package Insert and Label Information

JEUNCELL A DRUG FOR ATOPIC DERMATITIS — rumex crispus whole liquid
Jeun Cell Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

rumex crispus extract
wilfordi root extract, red ginseng extract, sesame seed extract, green tea extract, sea mustard extract, lemon extract, orange extract, arrow root extract, scutellaria root extract, soybean extract, dandelion extract, poncirus trifoliata fruit extract, zanthoxylum bungeanum extract, sanguisorba officinalis linne extract, pine needle extract
moisturizer for atopic skin
keep out of reach of the children – applied area: skin
– apply two-three times every day or often to the atopies and itchy skin rashes
– apply sufficient quantity to the intended part
When using this product
– keep out of eyes, ears, and mouth. If contact occurs, rinse with plenty of cold water right away and contact a physician. If swallowing, drink plenty of water and contact a physician for external use only

JEUNCELL A DRUG FOR ATOPIC DERMATITIS rumex crispus whole liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54296-1001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RUMEX CRISPUS WHOLE (RUMEX CRISPUS WHOLE) RUMEX CRISPUS WHOLE 5 mg in 100 mL

Inactive Ingredients Ingredient Name Strength BITTER ORANGE OIL TRIPTERYGIUM WILFORDII ROOT ASIAN GINSENG SESAME SEED GREEN TEA LEAF MUSTARD OIL LEMON ORANGE SCUTELLARIA LATERIFLORA TOP SOYBEAN PONCIRUS TRIFOLIATA FRUIT ZANTHOXYLUM BUNGEANUM FRUIT SANGUISORBA OFFICINALIS LEAF PINE NEEDLE OIL (PINUS MUGO)

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:54296-1001-1 100 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 11/25/2012

Labeler — Jeun Cell Ltd (688212024)

Registrant — Jeun Cell Ltd (688212024)

Establishment
Name	Address	ID/FEI	Operations
Jeun Cell Ltd		688212024	manufacture (54296-1001)

Revised: 11/2012 Jeun Cell Ltd