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Gyun e zero sterilization tissue

Approved
Approval ID

dd5856c9-a260-4fa8-8bef-2fc834185458

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 10, 2025

Manufacturers
FDA

Sunmedi

DUNS: 688954380

Products 1

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

ALCOHOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code75578-020
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
ALCOHOL
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 10, 2025
FDA Product Classification

INGREDIENTS (7)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
METHYLPROPANEDIOLInactive
Code: N8F53B3R4R
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
OCTYLDODECETH-16Inactive
Code: RJV574G0DE
Classification: IACT
ISOPROPYL ALCOHOLActive
Quantity: 70 g in 100 g
Code: ND2M416302
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/7/2020

PACKAGE LABEL - Gyun-e zero sterilization tissue (75pcs, 580g)

NDC: 75578-020-02

Image of container

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/7/2020

Uses

■ Hand sanitizer to help reduce bacteria that potentially can cause disease.

■ Isopropyl alcohol is a typical raw material for disinfectants.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/7/2020

Directions

■ Take out one sheet and wipe where sterilization is required.

■ Close the cap after use.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/7/2020

Active Ingredient

ISOPROPYL ALCOHOL 70.0%(w/w)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/7/2020

INACTIVE INGREDIENTS

Water, EDTA-2Na, Sodium Benzoate, Methyl Propanediol, Caprylyl Glycol, Ethylhexylglycerin, Octyldodeceth-16

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/7/2020

Purpose

Hand Sanitizer

WARNINGS SECTION

LOINC: 34071-1Updated: 8/7/2020

Warnings

First Aid
1. Wash with clean water when it gets into your eyes, and consult your doctor if you have any problems.
2. Take emergency measures to eat or swallow contents and Consult a doctor immediately.

Precautions for Use
1. Please follow the indicated usage and standard usage.
2. Be careful not to let the contents touch your eyes.
3. Do not inhale or drink.
4. Ventilate enough when using in an enclosed space.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/7/2020

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

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Gyun e zero sterilization tissue - FDA Drug Approval Details