AMULDY S: Package Insert and Label Information

AMULDY S- glycerin liquid
Lydia Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

glycerin

WATER, ALCOHOL, BUTYLENE GLYCOL, ETC

for skin protectant

relieve itchiness by providing moisture and nutrients to the dry skin

keep out of reach of the children

shake the container for 2 to 3 times before use, apply it evenly

■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist

red specks, swelling, itching

■ don’t use on the part where there is injury, eczema, or dermatitis

Keep out of reach of children

■ if swallowed, get medical help or contact a person control center immediately

for external use only

AMULDY S glycerin liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72988-0002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (GLYCERIN) GLYCERIN 8 g in 100 mL

Inactive Ingredients Ingredient Name Strength WATER ALLANTOIN

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:72988-0002-1 50 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part347 03/23/2019

Labeler — Lydia Co., Ltd. (695735569)

Registrant — Lydia Co., Ltd. (695735569)

Establishment
Name	Address	ID/FEI	Operations
Aloe Vera Korea Co.,Ltd.		687773350	manufacture (72988-0002)

Establishment
Name	Address	ID/FEI	Operations
Lydia Co., Ltd.		695735569	label (72988-0002)

Revised: 02/2021 Lydia Co., Ltd.