Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)
Lydia Co., Ltd.
TOPICAL
OTC DRUG
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
OTC monograph not final
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._ ---------- 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: 2/2021 Les hele dokumentet