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
package label
(click image for full-size original)
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

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