G AND Y ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

G AND Y ANTIBACTERIAL WET WIPES by

Drug Labeling and Warnings

G AND Y ANTIBACTERIAL WET WIPES by is a Otc medication manufactured, distributed, or labeled by ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

G AND Y ANTIBACTERIAL WET WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77613-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77613-011-20	20 in 1 PACKAGE	05/14/2020
1		3.5 mL in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 77613-011-90	90 in 1 PACKAGE	05/14/2020
2		3.5 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/14/2020

Labeler - ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI (565415460)

Establishment
Name	Address	ID/FEI	Business Operations
ERUSLU SAGLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI		565415460	manufacture(77613-011)