MedPath

Milia remover treatment

84735-009 Milia remover treatment

Approved
Approval ID

353b9e99-f839-24df-e063-6294a90a4725

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 16, 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.

Dioctyl Dimethyl Ammonium Chloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84735-009
Application NumberM028
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dioctyl Dimethyl Ammonium Chloride
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 16, 2025
FDA Product Classification

INGREDIENTS (8)

SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT
AMYLOPECTIN, UNSPECIFIED SOURCEInactive
Code: 4XO4QFV777
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
DIDECYLDIMONIUMActive
Quantity: 0.025 g in 100 g
Code: Z7F472XQPA
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
ICODEXTRINInactive
Code: 2NX48Z0A9G
Classification: IACT
BENZALKONIUMInactive
Code: 7N6JUD5X6Y
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/16/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/16/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/16/2025

Dioctyl Dimethyl Ammonium Chloride 0.025%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/16/2025

Disinfectant

WARNINGS SECTION

LOINC: 34071-1Updated: 5/16/2025

For extemal use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/16/2025

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/16/2025

When Using: when using, keep out of eyes, ears ,mouth and any open hurt skin area. In case of contact with eyes, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/16/2025

Stop Use: Stop using and ask a doctor if irritation or rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/16/2025

Keep Out Of Reach Of Children: Keep out of reach of children. if swallowed
get medical help or contact the Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/16/2025

1.Apply daily after deansing 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 perod of time until the miliadoesn't appear again.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/16/2025

Glycerin
Salicylic Acid
Dextrin
Xanthan Gum
Amylopectin
Tocopheryl Acetate
Dodecyl Dimethyl Benzyl Ammonium Chloride

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Milia remover treatment - FDA Drug Approval Details