MedPath

EyeOne Cleaner

Approved
Approval ID

37311080-b269-5ba2-e063-6394a90a2c6c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 10, 2025

Manufacturers
FDA

IDO PHARM

DUNS: 694853523

Products 1

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

Hyaluronic Acid, Tocopheryl Acetate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code77039-034
Product Classification
G
Generic Name
Hyaluronic Acid, Tocopheryl Acetate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 10, 2025
FDA Product Classification

INGREDIENTS (10)

ALPHA-TOCOPHEROL ACETATEActive
Quantity: 0.00001 g in 1 mL
Code: 9E8X80D2L0
Classification: ACTIB
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
1,2-HEXANEDIOLInactive
Code: TR046Y3K1G
Classification: IACT
PEG-8 CAPRYLIC/CAPRIC GLYCERIDESInactive
Code: 00BT03FSO2
Classification: IACT
PEG-6 CAPRYLIC/CAPRIC GLYCERIDESInactive
Code: GO50W2HWO8
Classification: IACT
POLOXAMER 184Inactive
Code: BIS92ZSF57
Classification: IACT
CAPRYLOYL GLYCINEInactive
Code: 8TY5YO42NJ
Classification: IACT
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYALURONIC ACIDActive
Quantity: 0.0000001 g in 1 mL
Code: S270N0TRQY
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 10/15/2024

12

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 10/15/2024

Use it whenever you need to clean your eyelids

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 10/15/2024

It is generally used twice a day, in the morning and evening.
Or use it whenever you need to clean your eyelids.
- Wash your hands thoroughly before use.
- Remove the pad after opening the packet.
- Close your eyes and wipe the eyelids and the base of your eyelashes with cloth.
- Once used, throw away cloth without fail.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 10/15/2024

Hyaluronic acid, Tocopheryl Acetate

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 10/15/2024

It cleans the area of eyebrow oil and glands and moisturizes the dryness around the eyes

WARNINGS SECTION

LOINC: 34071-1Updated: 10/15/2024

1. Consult a specialist if you have abnormal symptoms or side effects such as red spots, swelling, or itching due to direct sunlight during or after using this product.
2. Please refrain from using the wound area
3. Precautions for Storage and Handling
A. Please keep it out of the reach of children.
B. Please store it in a cool place.
4. Wash it immediately when it gets into your eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 10/15/2024

keep it out of the reach of children.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 10/15/2024

WATER,1,2-Hexanediol, Sodium Benzoate, PEG-8 CAPRYLIC/CAPRIC GLYCERIDES, PEG-6 CAPRYLIC/CAPRIC GLYCERIDES, POLOXAMER 184, Caprylyl Glycol, POLYSORBATE 20

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EyeOne Cleaner - FDA Drug Approval Details