EPONOL ANTIBACTERIAL HAND SANITIZER

EPONOL by

Drug Labeling and Warnings

EPONOL by is a Otc medication manufactured, distributed, or labeled by GUNSU ENERJI SISTEMLERI VE KONFOR TESISLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EPONOL ANTIBACTERIAL HAND SANITIZERHAND SANITIZER- alcohol liquid 
GUNSU ENERJI SISTEMLERI VE KONFOR TESISLERI SANAYI VE TICARET ANONIM SIRKETI

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.

----------

EPONOL ANTIBACTERIAL HAND SANITIZER

Drug Facts

Active ingredients

Ethyl Alcohol 70% 

Purpose

Antiseptic

Uses

hand sanitizer to decrease bacteria on the skin
recommended for repeated use

Warnings

Flammable, keep away from fire/flame For external only

Do not use
on open skin wounds

When using this product ▪In case of contact with eyes: Rinse immediately with running water for 30 minutes, keeping eyelids open. if remove contact lenses, if present. Call a doctor.

Stop use and ask a doctor if irritation and redness develop

Keep away from children, food and animal feeds.

Directions

Pour 5ml into your hand, scrub your hands during 60 seconds. It does not require rinsing.

Other information

do not store in direct sunlight
store below 50°C/ 105°F
avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

Water, Glycerine

Questions?

+1 (646) 591 - 0203

You may also report serious side effects to this phone number. (Mon-Fri 9:00 AM - 5:00 PM)

ALCOHOL BASED

Manufactured By

GUNSU ENERJI SISTEMLERI VE KONFOR TESISLERI SAN. VE TIC. A. S.

Organized Industrial Zone

Part 1 Ataturk Boulevard No: 25

07190 Dosemealti-ANTALYA

+90 242 258 11 40

info@gunsu.com.tr

www.gunsu.com.tr

Packaging

EPONOL  ANTIBACTERIAL HAND SANITIZERHAND SANITIZER
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78099-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	0.7 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78099-101-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020	12/31/2020
2	NDC: 78099-101-25	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020	12/31/2020
3	NDC: 78099-101-50	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020	12/31/2020
4	NDC: 78099-101-75	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020	12/31/2020
5	NDC: 78099-101-11	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/15/2020	12/31/2020
6	NDC: 78099-101-15	5000 mL in 1 CAN; Type 0: Not a Combination Product	04/15/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/15/2020	12/31/2020

Labeler - GUNSU ENERJI SISTEMLERI VE KONFOR TESISLERI SANAYI VE TICARET ANONIM SIRKETI (535289011)

Establishment
Name	Address	ID/FEI	Business Operations
GUNSU ENERJI SISTEMLERI VE KONFOR TESISLERI SANAYI VE TICARET ANONIM SIRKETI		535289011	manufacture(78099-101)

Revised: 1/2022

Document Id: 4573e9a4-e3af-4e53-8a7e-bab76f453d8b

34390-5

Set id: 66dcc1cd-0d4f-4956-b696-81f44ba1ceb8

Version: 2

Effective Time: 20220124

 

GUNSU ENERJI SISTEMLERI VE KONFOR TE