Gyun e zero sterilization tissue by Sunmedical

Gyun e zero sterilization tissue by

Drug Labeling and Warnings

Gyun e zero sterilization tissue by is a Otc medication manufactured, distributed, or labeled by Sunmedical. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

GYUN E ZERO STERILIZATION TISSUE- alcohol liquid 
Sunmedical

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredients 

Active ingredients: ISOPROPYL ALCOHOL 70.0%(w/w)

INACTIVE INGREDIENT

Inactive ingredients:

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

Purpose

Purpose: SANITIZER

Warnings

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:

■ It is a sterilized tissue that can be used for various purposes in hospitals, kitchen utensils, and students' hygiene.
■ Isopropyl alcohol is a typical raw material for disinfectants.

Directions

Directions:

■ Take out one sheet and wipe where sterilization is required.
■ Close the cap after use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GYUN E ZERO STERILIZATION TISSUE 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75578-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	350 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sodium Benzoate (UNII: OJ245FE5EU)
MethylPropanediol (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
Ethylhexylglycerin (UNII: 147D247K3P)
Octyldodeceth-16 (UNII: RJV574G0DE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75578-010-01	50 g in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2020	04/20/2020
2	NDC: 75578-010-02	900 g in 1 CONTAINER; Type 0: Not a Combination Product	04/01/2020	04/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/01/2020	04/20/2020

Labeler - Sunmedical (688954380)

Registrant - Sunmedical (688954380)

Establishment
Name	Address	ID/FEI	Business Operations
Sunmedical		688954380	manufacture(75578-010)

Revised: 4/2020

Document Id: 71c80a9e-ac88-4a0b-b034-7f09f5f0848d

34390-5

Set id: 6884e905-9b83-467b-a00e-146e8c5c1d74

Version: 3

Effective Time: 20200421

 

Sunmedical