MedPath

UTTSE Anti Fungal Shampoo.

83818-011

Approved
Approval ID

33bebbe9-e0ab-2f7d-e063-6294a90add4e

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Apr 27, 2025

Manufacturers
FDA

Shenzhen Xinxin Yunhai Technology Co., Ltd.

DUNS: 699816806

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Anti Fungal Shampoo

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83818-011
Application NumberM032
Product Classification
M
Marketing Category
C200263
G
Generic Name
Anti Fungal Shampoo
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 27, 2025
FDA Product Classification

INGREDIENTS (37)

POLYQUATERNIUM-10 (1000 MPA.S AT 2%)Inactive
Code: GMR4PEN8PK
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
C12-15 ALKYL BENZOATEInactive
Code: A9EJ3J61HQ
Classification: IACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEInactive
Code: B16G315W7A
Classification: IACT
SODIUM LAURETH SULFATEInactive
Code: BPV390UAP0
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FRAGRANCE 13576Inactive
Code: 5EM498GW35
Classification: IACT
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KX
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
C12-16 ALCOHOLSInactive
Code: S4827SZE3L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SOPHORA FLAVESCENS ROOTInactive
Code: IYR6K8KQ5K
Classification: IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)Inactive
Code: 8Z5ZAL5H3V
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
POLYQUATERNIUM-7Inactive
Code: 0L414VCS5Y
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
THYMUS VULGARIS LEAFInactive
Code: GRX3499643
Classification: IACT
MENTHOLInactive
Code: L7T10EIP3A
Classification: IACT
SODIUM ISOSTEAROYL LACTYLATEInactive
Code: 8730J0D3EV
Classification: IACT
DECYL GLUCOSIDEInactive
Code: Z17H97EA6Y
Classification: IACT
COCAMIDE MEAInactive
Code: C80684146D
Classification: IACT
CNIDIUM MONNIERI FRUITInactive
Code: V1IA3S3CUS
Classification: IACT
SALICYLIC ACIDActive
Quantity: 1 g in 100 mL
Code: O414PZ4LPZ
Classification: ACTIB
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEInactive
Code: H2KVQ74JM4
Classification: IACT
CURCUMA LONGA (TURMERIC) ROOTInactive
Code: 856YO1Z64F
Classification: IACT
LAURETH-23Inactive
Code: N72LMW566G
Classification: IACT
TEA-DODECYLBENZENESULFONATEInactive
Code: 8HM7ZD48HN
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM SULFATEInactive
Code: 0YPR65R21J
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
DIMETHICONOL (40 CST)Inactive
Code: 343C7U75XW
Classification: IACT
C12-13 ALKYL LACTATEInactive
Code: 9GLX7JL13M
Classification: IACT
ACACIA SENEGAL GUMInactive
Code: 5C5403N26O
Classification: IACT

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UTTSE Anti Fungal Shampoo. - FDA Drug Approval Details