SSANGBI TANG: Package Insert and Label Information

SSANGBI TANG- ginger, perilla frutescens leaf and pueraria montana var. lobata whole liquid
LYDIA 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.

galgeun-tang extract (pueraria lobata ohwi, perilla leaf, raw ginger, jujube, peony root, licorice, cinnamon bark)

cold, flu, other minor aches and pains due to headache and muscular aches

Keep out of reach of children

take 1 pouch 3 times a day

do not intake if the product is found to have expired or corrupted

when using this product be aware that the contents may flow when opening

stop use and ask a doctor if you have certain body types and allergies, it can cause a severe allergic reaction

water, liquid fructose

For oral use only

SSANGBI TANG galgeun-tang extract liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72988-0021 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GINGER (GINGER) GINGER 1.121 g in 100 mL PERILLA FRUTESCENS LEAF (PERILLA FRUTESCENS LEAF) PERILLA FRUTESCENS LEAF 1.121 g in 100 mL PUERARIA MONTANA VAR. LOBATA WHOLE (PUERARIA MONTANA VAR. LOBATA WHOLE) PUERARIA MONTANA VAR. LOBATA WHOLE 2.242 g in 100 mL

Inactive Ingredients Ingredient Name Strength FRUCTOSE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72988-0021-1 80 mL in 1 POUCH None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/08/2019

Labeler — LYDIA Co., Ltd (695735569)

Registrant — LYDIA Co., Ltd (695735569)

Establishment
Name	Address	ID/FEI	Operations
I World Pharmaceutical Co., Ltd		688222857	manufacture (72988-0021)

Establishment
Name	Address	ID/FEI	Operations
LYDIA Co., Ltd		695735569	label (72988-0021)

Revised: 10/2019 LYDIA Co., Ltd