AMULDY S- glycerin liquid
Aloe Vera Korea 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.

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Drug Facts

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

label

AMULDY S
glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82145-0001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	8 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82145-0001-1	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part347	08/04/2021

Labeler - Aloe Vera Korea Co.,Ltd. (687773350)

Registrant - Aloe Vera Korea Co.,Ltd. (687773350)

Name	Address	ID/FEI	Business Operations
Establishment
Aloe Vera Korea Co.,Ltd.		687773350	manufacture(82145-0001)

Revised: 7/2021

Document Id: c8b14b2a-5ce1-3a33-e053-2a95a90a679f

Set id: c8b14b2a-5ce0-3a33-e053-2a95a90a679f

Version: 1

Effective Time: 20210729

Aloe Vera Korea Co.,Ltd.