SHINMO SAENGBALEUM TREATMENT: Package Insert and Label Information

SHINMO SAENGBALEUM TREATMENT- panthenol gel
ATEC&CO INC.

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.

PANTHENOL 0.12%

Cleansing

Strengthen hair roots and scalp. Keeps the hair rich and
Healthy.

Apply a suitable amount to hair. After massaging gently, rinse with water.

For external use only.

Do not use on damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop using and ask a doctor if rash, swollenness, itching or stimulation occurs.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Water, Cetrimonium Chloride, Dimethicone, Trideceth-10, Cetearyl alcohol, Cetrimonium Chloride, Cyclopentasiloxane, Cyclohexasiloxane, BEHENYL ALCOHOL, Myristyl Alcohol, Butylene Glycol, Distearyldimonium Chloride, Stearamidopropyl Dimethylamine, Polyquaternium-10, Angelica Gigas Root Extract, Artemisia Princeps Leaf Extract, Sophora Angustifolia Root Extract, Cimicifuga Dahurica Root Extract, Angelica Dahurica Root Extract, Acorus Gramineus Root/Stem Extract, Punica Granatum Bark Extract, Saposhnikovia Divaricata Root Extract, Scutellaria Baicalensis Root Extract, Atractyloides Chinensis Rhizome Extract, Biota Orientalis Leaf Extract, Ceteareth-20, Benzyl Alcohol, Citric Acid, Betaine, Glycine Max (Soybean) Seed Extract, Lecithin, Simmondsia Chinensis (Jojoba) Seed Oil, Cetearyl Alcohol, Polysorbate 60, Sesamum Indicum (Sesame) Seed Extract, Oryza Sativa (Rice) Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Polygonum Multiflorum Root Extract, Camellia Sinensis Leaf Extract, Red Ginseng Extract, Portulaca Oleracea Extract, Rheum Palmatum Root Extract, Silkworm Extract, Bletia Hyacinthina Bulb Extract, Carthamus Tinctorius (Safflower) Flower Extract, Hydrolyzed Keratin, Caramel, Panthenyl Ethyl Ether, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance

SHINMO SAENGBALEUM TREATMENT panthenol gel

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69978-002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PANTHENOL (PANTHENOL) PANTHENOL 0.95 g in 958.50 g

Inactive Ingredients Ingredient Name Strength WATER CETRIMONIUM CHLORIDE TRIDECETH-10 CETOSTEARYL ALCOHOL CYCLOMETHICONE 5 CYCLOMETHICONE 6 DOCOSANOL MYRISTYL ALCOHOL BUTYLENE GLYCOL DISTEARYLDIMONIUM CHLORIDE STEARAMIDOPROPYL DIMETHYLAMINE POLYQUATERNIUM-10 (400 MPA.S AT 2%) ANGELICA GIGAS ROOT ARTEMISIA PRINCEPS LEAF SOPHORA FLAVESCENS ROOT ACTAEA DAHURICA ROOT ANGELICA DAHURICA ROOT ACORUS GRAMINEUS ROOT PUNICA GRANATUM ROOT BARK SAPOSHNIKOVIA DIVARICATA ROOT SCUTELLARIA BAICALENSIS ROOT ATRACTYLODES LANCEA ROOT PLATYCLADUS ORIENTALIS LEAF POLYOXYL 20 CETOSTEARYL ETHER BENZYL ALCOHOL CITRIC ACID MONOHYDRATE BETAINE SOYBEAN EGG PHOSPHOLIPIDS JOJOBA OIL POLYSORBATE 60 SESAME SEED RICE GERM GLYCYRRHIZA GLABRA FALLOPIA MULTIFLORA ROOT GREEN TEA LEAF ASIAN GINSENG PURSLANE RHEUM PALMATUM ROOT BLETILLA STRIATA BULB SAFFLOWER CARAMEL PANTHENYL ETHYL ETHER METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69978-002-02 1 BOTTLE in 1 CARTON contains a BOTTLE (69978-002-01) 1 NDC:69978-002-01 958.50 g in 1 BOTTLE This package is contained within the CARTON (69978-002-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/20/2015

Labeler — ATEC&CO INC. (689515243)

Registrant — ATEC&CO INC. (689515243)

Establishment
Name	Address	ID/FEI	Operations
ATEC&CO INC.		689515243	manufacture (69978-002)

Revised: 07/2015 ATEC&CO INC.