MedPath

HEALSURE SKIN PROTECTANT

84010-122

Approved
Approval ID

3602a8f1-3589-5793-e063-6294a90adbe4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 25, 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.

Dimethicone 2% SKIN PROTECTANT

PRODUCT DETAILS

NDC Product Code84010-122
Application NumberM016
Marketing CategoryC200263
Route of AdministrationTOPICAL
Effective DateMay 25, 2025
Generic NameDimethicone 2% SKIN PROTECTANT

INGREDIENTS (12)

GROWTH FACTOR RECEPTOR-BOUND PROTEIN 2Inactive
Code: Y5F0ROG9QC
Classification: IACT
ALOEInactive
Code: V5VD430YW9
Classification: IACT
PANCREATIC POLYPEPTIDEInactive
Code: UDH73690IV
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
GINKGOLIDE BInactive
Code: DF149B9460
Classification: IACT
BONGKREKIC ACIDInactive
Code: L7V4I673D2
Classification: IACT
DIMETHICONEActive
Quantity: 2 g in 100 g
Code: 92RU3N3Y1O
Classification: ACTIB
GENTIANA ACAULIS WHOLEInactive
Code: 0SR9G8J0FE
Classification: IACT
MATRINEInactive
Code: N390W430AC
Classification: IACT
SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT
LYSYL-PEG-LAUROYL-MODIFIED AMINO ACIDInactive
Code: H3EN7GDD53
Classification: IACT
LACTIC ACID, DL-Inactive
Code: 3B8D35Y7S4
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

·Temporarily protects and helps relieve chapped or cracked skin

·Effective on both old and new scars resulting from cuts, scrapes, burns,surgery, or aging.

OTC - STOP USE SECTION

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

Stop Use

·In case of having following symptoms after using this,you're advised to stop using it immediately. If you keep using it,the symptoms will get worse and need to consult a dermatologist:In case of having problems such as red rash,swelling, itching,stimulation during usage.

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredient

Dimethicone 2%

OTC - PURPOSE SECTION

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

Purpose

Skin protectant

WARNINGS SECTION

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

Warnings

·In case of having the same symptoms above on the part you put this product on by direct sunlight.

·You should avoid using this product under direct sunlight,especially on areas with scars, eczema, or dermatitis. ·In case of having following symptoms after using this,you're advised to stop using it immediately. If you keep using it,the symptoms will get worse and need to consult a dermatologist:In case of having problems such as red rash,swelling, itching,stimulation during usage.

OTC - DO NOT USE SECTION

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

Do not use

·In case of having the same symptoms above on the part you put this product on by direct sunlight.

OTC - WHEN USING SECTION

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

When Using

·You should avoid using this product under direct sunlight,especially on areas with scars, eczema, or dermatitis.

OTC - ASK DOCTOR SECTION

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

Ask Doctor

·In case of having following symptoms after using this,you're advised to stop using it immediately. If you keep using it,the symptoms will get worse and need to consult a dermatologist:In case of having problems such as red rash,swelling, itching,stimulation during usage.

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 babies and children, If swallowed, get medical help or contact a Poison Control Cente right away.

DOSAGE & ADMINISTRATION SECTION

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

Directions

·Gently massage into scar twice a day for 2-3 minutes

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 5/26/2025

Other information

Store at room temperature.

INACTIVE INGREDIENT SECTION

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

Inactive ingredients

Sodium Hyaluronate 、Glycine 、Salicylic Acid 、Ginkgolide B、Bongkrekic Acid 、Lactic Acid,Dl-、Pancreatic Polypeptide Growth Factor Receptor-Bound Protein 2 、Aloe、GentianaAcaulis Whole 、Matrine

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HEALSURE SKIN PROTECTANT - FDA Drug Approval Details