MedPath

Facial Cleansing Wipes

43116-041

Approved
Approval ID

36f7677a-ec73-e677-e063-6294a90ad480

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 7, 2025

Manufacturers
FDA

Shenzhen Shierjie Biological Engineering Co., LTD

DUNS: 547610261

Products 1

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

Facial Cleansing Wipes

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43116-041
Application NumberM006
Product Classification
M
Marketing Category
C200263
G
Generic Name
Facial Cleansing Wipes
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 7, 2025
FDA Product Classification

INGREDIENTS (17)

HYDROXYACETOPHENONEInactive
Code: G1L3HT4CMH
Classification: IACT
SALIX ALBA BARKInactive
Code: 205MXS71H7
Classification: IACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILInactive
Code: VIF565UC2G
Classification: IACT
ROSA CANINA FRUIT OILInactive
Code: CR7307M3QZ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SESAME SEEDInactive
Code: 7Y1255HVXR
Classification: IACT
NIACINAMIDEInactive
Code: 25X51I8RD4
Classification: IACT
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
CHRYSANTHELLUM INDICUM TOPInactive
Code: STJ856D1Z0
Classification: IACT
SALICYLIC ACIDActive
Quantity: 1 U in 100 U
Code: O414PZ4LPZ
Classification: ACTIB
SIMMONDSIA CHINENSIS (JOJOBA) SEED OILInactive
Code: 724GKU717M
Classification: IACT
ALOE BARBADENSIS LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
CENTELLA ASIATICA TRITERPENOIDSInactive
Code: 4YS74Q4G4J
Classification: IACT
PURSLANEInactive
Code: M6S840WXG5
Classification: IACT
LIMOSILACTOBACILLUS FERMENTUMInactive
Code: 2C1F12C6AP
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/9/2025

PRINCIPAL DISPLAY PANEL

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INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/9/2025

Use

1.Relief Acne
2.Four in one for skin care: Gentle cleanse, hydrate, balance and nourish.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/9/2025

Warnings

●For external use only.
●Disposable wipes, one-time use only.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/9/2025

Active Ingredient

SAL ICYLIC ACID 1%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/9/2025

Purpose

Acne

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/9/2025

Do not use

1. If you are allergic to salicylic acid or any ingredient in this product
2. On children under 12 years (unless directed by doctor)
3. On inflamed/weeping skin or open wounds

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/9/2025

When Using

1.Avoid contact with eyes, lips, and mouth. If contact occurs, rinse thoroughly with water.
2.Use 1-2 times daily or as directed by doctor.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/9/2025

Stop Use

Stop use and ask a doctor if irtation or rash appears and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/9/2025

Keep Oot Of Reach Of Children

To avid the isk of chocking and ufocationnn keep wipes and plastic bag awoy
from babieschildren and pets.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/9/2025

Directions

1. Use daily before applying skin treatment, mask or moisturizer.
2. Lift seal and remove cleaning cloth, gently wipe face,removing dirt, sweat, oil and make up.
3. There is no need to rinse. Avoid direct contact with eyes and mouth. Reseal package tightly to keep cloths moist.
4. Dispose of cleansing cloth in the trash. Do not Flush!

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 6/9/2025

Other information

●Store below 106°F (41°C )
●Store in a cool, dry and airy place.
●Validity period for 2 years.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/9/2025

Inactive ingredients

Water, Glycerin, Sesame Amino Acids, Niacinamide, Butylene Glycol, Chrysanthellum
Indicum Extract, Centella Asiatica Extract, Portulaca Oleracea Extract,
Aloe Barbadensis Extract, Salix Alba (Willow) Bark Extract Simmondsia
Chinensis(Jojoba)Seed Oil,Melaleuca Alternifolia (TeaTree) Leaf Oil,Lactobacillus
Ferment Lysate,Rosa Canina Fruit Oil,1,2-Hexanediol,Hydroxyacetophenone

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Facial Cleansing Wipes - FDA Drug Approval Details