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MILIA REMOVER TREATMENT

MILIA REMOVER TREATMENT

Approved
Approval ID

31b27fa8-6f54-a265-e063-6394a90a19c3

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 21, 2025

Manufacturers
FDA

Hengyang Chuangjiujia Trading Co., Ltd.

DUNS: 977292157

Products 1

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

Dideoyl Dimethyl Ammonium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84735-006
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dideoyl Dimethyl Ammonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 21, 2025
FDA Product Classification

INGREDIENTS (6)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT
DIDECYLDIMONIUMActive
Quantity: 0.025 g in 100 mL
Code: Z7F472XQPA
Classification: ACTIB
DIHYDROMYRICETINInactive
Code: KD8QND6427
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/1/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 4/1/2025

Uses: temporarily relieves these symptoms dueto hay fever or other upper respiratory allergies

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/1/2025

Dideoyl Dimethyl Ammonium Chloride 0.025%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 4/1/2025

Disinfectant

WARNINGS SECTION

LOINC: 34071-1Updated: 4/1/2025

For extemal use only, Stop using and ask a doctorif rash or initation happens.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 4/1/2025

Do not use: In children less than 2years old. On open skin wounds.

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 4/1/2025

When Using: when using, keepout of eyes, ears ,mouth and anyopen hurt skin area.In case ofcontact with eyes, rinse eyesthoroughly with water.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 4/1/2025

Stop Use: Stop using and ask adoctor if irritation or rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 4/1/2025

Keep out of reach of children. lf swallowed, get medical help orcontact the Poison Control Centerright away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 4/1/2025

1. Apply daily after cleansing and toning. Twice aday for at least 4 weeks.
2.Dispense a pea-size amount of the essence ontothe problematic area and use fingertips to massageuntil fully absorbed.
3.keep using it for a period of time until the miliadoesn't appear again.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/1/2025

Glycerin
Salicylic acid
Xanthan gum
Ampelopsin
Tocopheryl Acetate

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MILIA REMOVER TREATMENT - FDA Drug Approval Details