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HEALSURE ACNE TREATMENT

84010-123

Approved
Approval ID

360639e6-85c1-c30c-e063-6294a90a423a

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 26, 2025

Manufacturers
FDA

Jiangxi Hemei Pharmaceutical Co., Ltd

DUNS: 724892056

Products 1

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

Salicylic Acid 2% ACNE TREATMENT

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84010-123
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
Salicylic Acid 2% ACNE TREATMENT
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 26, 2025
FDA Product Classification

INGREDIENTS (10)

CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
SOPHORA FLAVESCENS WHOLEInactive
Code: X8KX602M5L
Classification: IACT
GLYCINEInactive
Code: TE7660XO1C
Classification: IACT
GINKGOInactive
Code: 19FUJ2C58T
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MENTHA PIPERITAInactive
Code: 79M2M2UDA9
Classification: IACT
GLYCERYL 1-STEARATEInactive
Code: 258491E1RZ
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
SALICYLIC ACIDActive
Quantity: 2 g in 100 g
Code: O414PZ4LPZ
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/26/2025

PRINCIPAL DISPLAY PANEL

1

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/26/2025

Use

·For the treatment of acne

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 5/26/2025

Do not use

·if you have very sensitive skin

·if you are sensitive to salicylic acid

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/26/2025

Active Ingredient

Salicylic Acid 2%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/26/2025

Purpose

Acne Treatment

WARNINGS SECTION

LOINC: 34071-1Updated: 5/26/2025

Warnings

·For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 5/26/2025

When Using

·skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time, lf irritation occurs, only use one topical acne medication at a time.

·avoid unnecessary sun exposure and use a sunscreen ·avoid contact with eves.hair and dyedavoio contact with eves.lips and mouth · avoid contact with hair and dyed fabrics, which may be bleached by this product

· skin irritation may occur.characterized by redness, burning, itching, peeling, or possibly swelling. lrritatior may be reduced by using the product less frequently or in a lower concentration

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 5/26/2025

Stop Use

·irritation becomes severe

· Keep out of reach of children.

· lf swallowed, get medical help or contact Poison Control Center right away

OTC - ASK DOCTOR SECTION

LOINC: 50569-3Updated: 5/26/2025

Ask Doctor

·irritation becomes severe

· Keep out of reach of children.

· lf swallowed, get medical help or contact Poison Control Center right away

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/26/2025

Keep Out Of Reach Of Children

· Keep out of reach of children.

· lf swallowed, get medical help or contact Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/26/2025

Directions

·clean the skin thoroughly before applying this product

·cover the entire affected area with a thin layer one or three times daily ·because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor

· if bothersome dryness or peeling occurs, reduce application to once a day or every other day

·if goina outside, apply sunscreen after using this product. lf irritation or sensitivity develops, stop use of both products and ask a doctor.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/26/2025

Inactive ingredients

Glycine,Sophora Flavescens whole, Ginkgo, Glycerol, Propylene Glycol, Mentha Piperita, Cetostearyl Alcohol, Glyceryl 1-Stearate, Peregal O-20

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HEALSURE ACNE TREATMENT - FDA Drug Approval Details