Plalab Placenta Peeling: Package Insert and Label Information

PLALAB PLACENTA PEELING- juglans regia shell gel
RENOCELL Co., 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.

Juglans Regia (Walnut) Shell Powder (0.5%)

Exfoliation

Keep out of reach of children — Do not swallow. In case of accidental ingestion, seek professional assistance.

Delivers gentle exfoliation for cleansing results. Helps to remove dead skin. Moisturizes the skin. Keep skin soft and smooth.

Warnings
For external use only
Do not use when Your skin is red, inflamed, irritated or painful
When using this product  Do not apply on other parts of the body  Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.  Do not apply directly to wound or open cut. Stop use and ask doctor if rash or irritation on skin develops and lasts. Store at room temperature

Directions After washing the face, apply the adequate amount on well dried skin avoiding around eyes and mouth. Gently massage onto the face with the fingertip dipping water slightly. Rinse clean with lukewarm water. Use 1-2 times a week.

Water, Glycerin, Butylene Glycol, Dipropylene Glycol, Diethoxyethyl Succinate, PEG-5 Glyceryl Stearate, Triethylhexanoin, 1,2-Hexanediol, PEG-40 Hydrogenated Castor Oil, Placental Protein, Polyethylene, Arginine, Carbomer, Panthenol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Fragrance, Vitis Vinifera (Grape) Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Citrus Limon (Lemon) Fruit Extract, Citrus Aurantifolia (Lime) Fruit Extract, Disodium EDTA

Plalab Placenta Peeling Gel

PLALAB PLACENTA PEELING juglans regia shell gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70326-101 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength JUGLANS REGIA SHELL (JUGLANS REGIA SHELL) JUGLANS REGIA SHELL 0.005 in 80 mL

Inactive Ingredients Ingredient Name Strength WATER Glycerin Butylene Glycol Dipropylene Glycol Diethoxyethyl Succinate PEG-5 Glyceryl Stearate Triethylhexanoin 1,2-Hexanediol POLYOXYL 40 HYDROGENATED CASTOR OIL SUS SCROFA PLACENTA HIGH DENSITY POLYETHYLENE ARGININE CARBOXYPOLYMETHYLENE Panthenol CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) WINE GRAPE ORANGE APPLE LEMON LIME (CITRUS) EDETATE DISODIUM

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70326-101-02 1 TUBE in 1 PACKAGE contains a TUBE (70326-101-01) 1 NDC:70326-101-01 80 mL in 1 TUBE This package is contained within the PACKAGE (70326-101-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/22/2015

Labeler — RENOCELL Co., Ltd (689605795)

Registrant — RENOCELL Co., Ltd (689605795)

Establishment
Name	Address	ID/FEI	Operations
RENOCELL Co., Ltd		689605795	manufacture (70326-101)

Revised: 12/2015 RENOCELL Co., Ltd