G AND Y ANTIBACTERIAL HAND WIPES- benzalkonium chloride cloth 
ERUSLU SAGLIK URUNLERI 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.

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G&Y Antibacterial Hand Wipes

Drug Facts

Active ingredients

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin

Warning

For external use only

Do not use

▪ in the eyes.
▪ if you are allergic to any of the ingredients.

When using this product  if eye contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Keep out of reach of children.  ▪  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Storage. Store at room temperature.

• Dispensing. Remove seal band. Lift tab at front of lid. Pull out wipe and reseal lid. Close lid to retain moisture.

• Use. Apply wipe thoroughly to hands as desired. Allow to dry without wiping.

• Disposal. Dispose of used wipes in trash receptacle after use. Do not flush.

Other information

Production Date, Expiry Date and Lot Number on side

Inactive ingredients

Benzoic Acid, C12-15 Pareth-12, Dehydroacetic Acid, Fragrance, Glycerin, Phenoxyethanol, Purified Water, Tetrasodium Glutamate Diacetate.

Kills 99.9% of Germs that may cause illness.

6.3 IN x 7.1 IN
(16 cm x 18 cm)

Questions? +1 (862) 257-3339

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

Distributed by: G&Y Products, Inc.

25 Shady St, Paterson, NJ 07524

info@gyproduct.com

Country of origin : Turkey

Packaging

image description

G AND Y ANTIBACTERIAL HAND WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77613-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID (UNII: 8SKN0B0MIM)  
C12-15 PARETH-12 (UNII: 131316X18L)  
DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
WATER (UNII: 059QF0KO0R)  
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77613-010-2020 in 1 PACKAGE05/14/2020
13.5 mL in 1 PACKET; Type 0: Not a Combination Product
2NDC:77613-010-9090 in 1 PACKAGE05/14/2020
23.5 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/14/2020
Labeler - ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (565415460)
Establishment
NameAddressID/FEIBusiness Operations
ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI565415460manufacture(77613-010)

Revised: 5/2020
Document Id: ba20a596-6dd2-42a1-9faf-d012f7f59c32
Set id: 548452d1-1c35-468e-a424-b14b6e7cbf33
Version: 1
Effective Time: 20200514
 
ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI