AMULDY S- glycerin liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)
Available from:
Lydia Co., Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
for skin protectant relieve itchiness by providing moisture and nutrients to the dry skin shake the container for 2 to 3 times before use, apply it evenly
Authorization status:
OTC monograph not final
Authorization number:
72988-0002-1

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.

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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

AMULDY S

glycerin liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:729 8 8 -0 0 0 2

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

GLYCERIN (UNII: PDC6 A3C0 OX) (GLYCERIN - UNII:PDC6 A3C0 OX)

GLYCERIN

8 g in 10 0 mL

Lydia Co., Ltd.

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALLANTO IN (UNII: 344S277G0 Z)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:729 8 8 -0 0 0 2-1

50 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 3/23/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt347

0 3/23/20 19

Labeler -

Lydia Co., Ltd. (695735569)

Registrant -

Lydia Co., Ltd. (695735569)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Alo e Vera Ko rea Co .,Ltd.

6 8 7773350

ma nufa c ture (729 8 8 -0 0 0 2)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Lydia Co ., Ltd.

6 9 573556 9

la be l(729 8 8 -0 0 0 2)

Revised: 3/2019

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