FDA Product

OURUI ONE FUNGAL NAIL TREATMENT

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

OURUI ONE FUNGAL NAIL TREATMENT

FDA Product Code

84010-100

Regulatory Information

NDC Product Code

84010-100

Application Number

M005

Marketing Category

C200263

Effective Date

April 14, 2025

Territorial Authority

USA

FDA Title

84010-100

Labeling Type

HUMAN OTC DRUG LABEL

Version Number

1

Company Information

ManufacturerJiangxi Hemei Pharmaceutical Co., Ltd

DUNS Number

724892056

Active Ingredients

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

RESORCINOL

Code: YUL4LO94HK

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

HYDRACRYLIC ACID

Code: C4ZF6XLD2X

Class Code: IACT

PSEUDOLARIX AMABILIS BARK

Code: 49G13A93VE

Class Code: IACT

Quantity: 1 g in 100 mL

Code: 06KB629TKV

Class Code: ACTIB

EUPHORBIA HIRTA WHOLE

Code: L13YF113GN

Class Code: IACT

Active Moieties

TOLNAFTATE

Code: 06KB629TKV

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