MedPath

Anti-wrinkle eye cream

Approved
Approval ID

37f84240-942f-9028-e063-6294a90a41ad

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 19, 2025

Manufacturers
FDA

Guangzhou Yapeng Refinement Chemical Co., Ltd.

DUNS: 529423510

Products 1

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

eye cream

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code84356-005
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
eye cream
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 19, 2025
FDA Product Classification

INGREDIENTS (10)

SQUALANEInactive
Code: GW89575KF9
Classification: IACT
SODIUM HYALURONATEInactive
Code: YSE9PPT4TH
Classification: IACT
CAFFEINEActive
Quantity: 2 g in 100 mL
Code: 3G6A5W338E
Classification: ACTIB
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
ACETYL HEXAPEPTIDE-8Active
Quantity: 0.02 g in 100 mL
Code: L4EL31FWIL
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
NIACINAMIDEActive
Quantity: 3 g in 100 mL
Code: 25X51I8RD4
Classification: ACTIB
AQUAInactive
Code: 059QF0KO0R
Classification: IACT
CETEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/20/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/23/2025

Temporarily reduces under-eye puffiness
Helps improve the appearance of dark circles
Minimizes the look of fine lines and wrinkles

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/23/2025

Stop use and consult a doctor if irritation persists or worsens.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 6/23/2025

If you are allergic to any of the ingredients.
On broken or irritated skin.
When using this product Discontinue use if redness,irritation, or swelling occurs.
Keep away from the eye contour to prevent stinging.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/23/2025

Keep out of reach of children,The above warning signs have been listed in the labels

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/23/2025

Temporarily reduces under-eye puffiness
Helps improve the appearance of dark circles
Minimizes the look of fine lines and wrinkles

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/23/2025

Apply a small amount to the under-eye area using gentle patting motions.
Use once or twice daily,preferably in the morning and/or evening.
Avoid direct contact with eyes.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/23/2025

Do not take orally. If swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/23/2025

Aqua,Glycerin,Squalane,Sodium Hyaluronate,Cetearyl
Alcohol, Phenoxyethanol, Ethylhexylglycerin

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